Stryker and Wright Medical; Analysis of Consent Orders To Aid Public Comment, 71340-71343 [2020-24813]

Download as PDF 71340 Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices are Permanent records and will be transferred to the National Archives at the time that related permanent records are transferred (DAA–GRS–2015–0001– 0002). • Committee Accountability Records Æ Records that document financial and ethics accountability, such as records documenting financial expenditures associated with the functioning of the committee and financial disclosure and conflict of interest documents. These are Temporary records that do not contain unique information of historical value and are destroyed or deleted when six years old or when no longer required for business purposes (DAA–GRS–2015– 0001–0004). • Non-substantive Committee Records Æ Records related to specific committees that are of an administrative nature or are duplicative of information maintained elsewhere. These are Temporary records to be destroy when superseded, obsolete, no longer needed, or upon termination of the committee, whichever is sooner. (DAA–GRS–2015– 0001–0005). • Committee Management Records Æ Records created and/or maintained by Committee Management Officers (CMOs) and their staff related to the overall management of committees for an agency. These records may pertain to specific committees or to the committee management function in general. These are Temporary records to be destroy when 3 years old, 3 years after submission of report, or 3 years after superseded or obsolete, as appropriate. Longer retention is authorized if required for business use. (DAA–GRS– 2015–0001–0006). The FCC disposes of the paper documents by shredding. The electronic records, files, and data are destroyed either by physical destruction of the electronic storage media or by erasure of the data. khammond on DSKJM1Z7X2PROD with NOTICES ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS: 16:35 Nov 06, 2020 Jkt 253001 RECORDS ACCESS PROCEDURES: Individuals wishing to request access to and/or amendment of records about themselves should follow the Notification Procedure below. FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Notice of Board Meeting November 16, 2020 at 10:00 a.m. Telephonic. Dial-in (listen only) information: Number: 1–877–446– 3914, Code: 2094665. FOR FURTHER INFORMATION CONTACT: Kimberly Weaver, Director, Office of External Affairs, (202) 942–1640. SUPPLEMENTARY INFORMATION: Board Meeting Agenda DATES: ADDRESSES: Open Session 1. Approval of the October 19, 2020 Board Meeting Minutes 2. Monthly Reports (a) Investment Performance (b) Legislative Report 3. Quarterly Reports (c) Metrics 4. Multi-Asset Manager Update Adjourn Dated: November 4, 2020. Dharmesh Vashee, Acting General Counsel, Federal Retirement Thrift Investment Board. [FR Doc. 2020–24779 Filed 11–6–20; 8:45 am] BILLING CODE P CONTESTING RECORD PROCEDURES: Individuals wishing to request an amendment of records about themselves should follow the Notification Procedure below. NOTIFICATION PROCEDURE: Individuals wishing to determine whether this system of records contains information about themselves may do so by writing to Privacy Team, Federal Communications Commission, 45 L Street NE, Washington, DC 20554, or Privacy@fcc.gov. Individuals requesting access must also comply with the FCC’s Privacy Act regulations regarding verification of identity to gain access to the records (47 CFR part 0, subpart E). EXEMPTIONS PROMULGATED FOR THE SYSTEM: 1. FACA paper records documents, records, and files (except OGE Form 450 files) are maintained in file cabinets in the office suites of the DFO’s Bureau or Office (B/O). These file cabinets are locked at the end of each business day. Access to each office suite is through a card-coded main door. Access to these files is restricted to the PERM supervisors and staff and to the DFO’s authorized supervisors and staff in each Bureau or Office; 2. Paper copies of OGE Form 450 files, documents, and records are maintained in file cabinets in the OGC office suite. VerDate Sep<11>2014 These file cabinets are locked at the end of each business day. Access to the OCG OGC office suite is through a card-coded main door. Access to these files is restricted to OGC supervisors and staff; and 3. Access to non-public FACA electronic records, files, and data, which are housed in the FCC’s computer network databases, is restricted to authorized PERM supervisors and staff; to the supervisors and staff in each DFO’s Bureau/Office; to the OGC supervisors and staff for OGE Form 450 files and associated vetting documentation; and to the Information Technology (IT) staff and contractors, who maintain the FCC’s computer network. Other FCC employees and contractors may be granted access only on a ‘‘need-to-know’’ basis. The records in the FCC’s computer network are protected by the FCC’s security protocols, which include controlled access, passwords, and other IT safety and security features. None. HISTORY: The FCC last gave full notice of this system of records, FCC/OMD–3, Federal Advisory Committee Act (FACA) Membership Files, by publication in the Federal Register on October 13, 2013 (78 FR 63196). Federal Communications Commission. Cecilia Sigmund, Federal Register Liaison Officer. [FR Doc. 2020–24730 Filed 11–6–20; 8:45 am] BILLING CODE 6712–01–P PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 FEDERAL TRADE COMMISSION [File No. 201–0014] Stryker and Wright Medical; Analysis of Consent Orders To Aid Public Comment Federal Trade Commission. Proposed consent agreement; request for comment. AGENCY: ACTION: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations. DATES: Comments must be received on or before December 9, 2020. ADDRESSES: Interested parties may file comments online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write: ‘‘Stryker and Wright Medical; File No. 201 0014’’ on your comment, and file your comment online at https://www.regulations.gov by following the instructions on the webbased form. If you prefer to file your comment on paper, please mail your SUMMARY: E:\FR\FM\09NON1.SGM 09NON1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC–5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. FOR FURTHER INFORMATION CONTACT: Jonathan Ripa (202–326–2230), Bureau of Competition, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580. SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis of Agreement Containing Consent Orders to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC website at this web address: https:// www.ftc.gov/news-events/commissionactions. You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before December 9, 2020. Write ‘‘Stryker and Wright Medical; File No. 201 0014’’ on your comment. Your comment— including your name and your state— will be placed on the public record of this proceeding, including, to the extent practicable, on the https:// www.regulations.gov website. Due to the public health emergency in response to the COVID–19 outbreak and the agency’s heightened security screening, postal mail addressed to the Commission will be subject to delay. We strongly encourage you to submit your comments online through the https:// www.regulations.gov website. If you prefer to file your comment on paper, write ‘‘Stryker and Wright Medical; File No. 201 0014’’ on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC–5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex VerDate Sep<11>2014 16:35 Nov 06, 2020 Jkt 253001 D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. Because your comment will be placed on the publicly accessible website at https://www.regulations.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include sensitive personal information, such as your or anyone else’s Social Security number; date of birth; driver’s license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure your comment does not include sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any ‘‘trade secret or any commercial or financial information which . . . is privileged or confidential’’—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled ‘‘Confidential,’’ and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on https:// www.regulations.gov—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from that website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request. Visit the FTC website at http:// www.ftc.gov to read this Notice and the news release describing this matter. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 71341 consider all timely and responsive public comments that it receives on or before December 9, 2020. For information on the Commission’s privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/ privacy-policy. Analysis of Consent Orders To Aid Public Comment I. Introduction The Federal Trade Commission (‘‘Commission’’) has accepted, subject to final approval, an Agreement Containing Consent Orders (‘‘Consent Agreement’’) from Stryker Corporation (‘‘Stryker’’) designed to remedy the anticompetitive effects resulting from Stryker’s proposed acquisition of Wright Medical Group N.V. (‘‘Wright’’). The proposed Decision and Order (‘‘Order’’) contained in the Consent Agreement requires Stryker to divest all rights and assets related to its total ankle replacement and finger joint implant businesses to DJO Global, Inc. (‘‘DJO’’). The proposed Consent Agreement has been placed on the public record for thirty days for receipt of comments from interested persons. Comments received during this period will become part of the public record. After thirty days, the Commission will review the comments received and decide whether it should withdraw, modify, or make the Consent Agreement final. Under the terms of the Purchase Agreement dated November 4, 2019, Stryker will acquire all of the outstanding shares of Wright for a total equity value of approximately $4 billion (‘‘the Acquisition’’). The Commission’s Complaint alleges that the proposed Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by substantially lessening competition in the U.S. markets for total ankle replacements and finger joint implants. The proposed Consent Agreement would remedy the alleged violations by preserving the competition that otherwise would be lost in these markets as a result of the proposed Acquisition. II. The Parties Stryker is a global medical device company based in Kalamazoo, Michigan. Stryker organizes its business operations into three segments: Orthopedics; medical and surgical; and neurotechnology and spine. Headquartered in Amsterdam, the Netherlands, Wright is a global medical device company focused on extremities E:\FR\FM\09NON1.SGM 09NON1 71342 Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices and biologics products. Wright divides its business into four categories: Upper extremities; lower extremities; biologics products; and sports medicine. III. The Relevant Products and Market Structures a. Total Ankle Replacements Total ankle replacements are used to treat end-stage ankle arthritis, in which the cartilage on the tibia (shin), talus (top of the foot), and fibula (calf) bones that form the ankle joint has worn away to create bone-on-bone grinding. Patients with end-stage ankle arthritis— typically aged fifty and older— experience severe pain and swelling of the ankle along with difficulty walking. Total ankle replacements reduce pain while maintaining, and even increasing, ankle motion. In a total ankle replacement procedure, a surgeon removes damaged portions of bone and cartilage and replaces it with a threepiece system. A metal tibial tray, a metal talar dome, and a plastic insert (polyethylene bearing) mimic the cartilage in the joint. In a fixed bearing total ankle replacement, the polyethylene bearing is locked to the tibial component, while in a mobile bearing system it moves independently. Physicians and their patients would not switch to an alternative product or therapy in response to a small but significant increase in the price of total ankle replacements. Wright and Stryker are the first and third-largest suppliers in the United States, respectively, of total ankle replacements, while Integra LifeSciences (‘‘Integra’’) is the secondlargest supplier. Exactech, Inc. and Zimmer Biomet also supply total ankle replacement products but have only small shares of the U.S. ankle replacement market. Together, Stryker and Wright would account for approximately 75 percent of the market. khammond on DSKJM1Z7X2PROD with NOTICES b. Finger Joint Implants Finger joint implants are used to treat advanced osteoarthritis and are implanted into a patient’s proximal interphalangeal joints or metacarpophalangeal joints through a surgical procedure to replace damaged bone and cartilage. Arthritis is a gradual, progressive condition typically treated in stages. Physicians seek to use the least invasive treatment option possible to meet each patient’s needs, using finger joint implants only when all other options have failed. Physicians and their patients would not switch to an alternative product or therapy in response to a small but significant VerDate Sep<11>2014 16:35 Nov 06, 2020 Jkt 253001 increase in the price of finger joint implants. Stryker and Wright are two of only three significant suppliers for finger joint implants in the United States. Integra is the leading supplier while Stryker and Wright are the second and third-largest suppliers, respectively. BioPro Implants (‘‘BioPro’’) is the only other supplier of finger joint implants in the United States but has a very small share of the U.S. finger joint implant market. The combined Stryker and Wright would have a market share in the United States in excess of 50 percent. III. The Relevant Geographic Markets The United States is the relevant geographic market in which to assess the competitive effects of the proposed Acquisition. Total ankle replacements and finger joint implants are medical devices regulated by the U.S. Food and Drug Administration (‘‘FDA’’). As such, total ankle replacements and finger joint implants sold outside the United States, but not approved for sale in the United States, do not provide viable competitive alternatives for U.S. consumers. IV. Competitive Effects of the Acquisition The proposed Acquisition would likely result in substantial competitive harm to consumers in the markets for total ankle replacements and finger joint implants. As suppliers of close substitutes in each relevant market, Stryker and Wright respond directly to competition from each other with improved products, better service, and lower prices. By eliminating this direct and substantial head-to-head competition, the proposed Acquisition likely would allow the combined firm to exercise market power unilaterally, resulting in less innovation and higher prices for consumers. V. Entry Conditions Entry in the relevant markets would not be timely, likely, or sufficient in magnitude, character, and scope to deter or counteract the anticompetitive effects of the proposed Acquisition. To enter or effectively expand in either relevant market successfully, a supplier would need to design and manufacture an effective product, obtain FDA approval, and develop clinical history supporting the long-term efficacy of its product. The new entrant or expanding firm would also need to develop and foster product loyalty and establish a nationwide sales network capable of marketing the product and providing on-site service at hospitals nationwide. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Establishing a track record for quality, service, and consistency is difficult, expensive, and typically requires several years. VI. The Consent Agreement The Consent Agreement eliminates the competitive concerns raised by the proposed Acquisition by requiring the parties to divest to DJO all of the rights and assets needed for it to become an independent, viable, and effective competitor in the U.S. markets for total ankle replacements and finger joint implants. The divestitures will maintain the competition that currently exists in each of the relevant markets. DJO is well positioned to restore the competition that otherwise would be lost through the proposed Acquisition. Headquartered in Vista, California, DJO is a global medical device company that has experience manufacturing, marketing, and distributing orthopedic devices in the United States, and a track record for quality, service, and consistency. DJO’s lower and upper extremity product portfolio is also highly complementary to Stryker’s total ankle replacements and finger joint implants. The Order requires Stryker to divest all assets related to the divested businesses other than real property and tangible personal property. The divested assets include all inventory, contracts, permits, intellectual property (‘‘IP’’), and business information related to Stryker’s total ankle replacement and finger joint implant products. Certain IP, which Stryker uses for both the divested products as well as retained products, will be retained by Stryker and licensed to DJO. To ensure continuity for customers, the Order requires that Stryker supply DJO with transition assistance sufficient to efficiently transfer the total ankle replacement and finger joint implant assets to DJO and to assist DJO in operating the assets and business, in all material respects, in the manner in which Stryker did prior to the proposed Acquisition. Until DJO obtains FDA approval to become the legal manufacturer of the products, Stryker will act as an intermediary supplier for DJO. Further, the Order requires that the parties transfer all confidential business information to DJO, as well as provide access to employees who possess or are able to identify such information. DJO also will have the right to interview and offer employment to employees associated with the relevant products. The parties must accomplish these divestitures and relinquish their rights to DJO no later than ten days after the proposed Acquisition is consummated. E:\FR\FM\09NON1.SGM 09NON1 Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices If the Commission determines that DJO is not an acceptable acquirer, or that the manner of the divestitures is not acceptable, the proposed Order requires the parties to unwind the sale of rights to DJO and then divest the products to a Commission-approved acquirer within six months of the date the Order becomes final. The proposed Order further allows the Commission to appoint a trustee in the event the parties fail to divest the products as required. The Order also requires the parties to appoint Justin Menezes, from Mazars, as interim monitor to ensure the parties comply with the obligations pursuant to the Consent Agreement and to keep the Commission informed about the status of the transfer of the assets and rights to DJO. The purpose of this analysis is to facilitate public comment on the Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Order or to modify its terms in any way. By direction of the Commission. April J. Tabor, Acting Secretary. [FR Doc. 2020–24813 Filed 11–6–20; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3404–PN] Medicare and Medicaid Programs: Application From the Joint Commission for Continued Approval of Its Hospice Accreditation Program Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice with request for comment. AGENCY: This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 9, 2020. ADDRESSES: In commenting, refer to file code CMS–3404–PN. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:35 Nov 06, 2020 Jkt 253001 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the ‘‘Submit a comment’’ instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–3404–PN, P.O. Box 8010, Baltimore, MD 21244–8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–3404–PN, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. Submission of comments on paperwork requirements. You may submit comments on this document’s paperwork requirements by following the instructions at the end of the ‘‘Collection of Information Requirements’’ section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Caecilia Blondiaux, (410) 786–2190. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http:// www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. I. Background Under the Medicare program, eligible beneficiaries may receive covered services in a hospice, provided that certain requirements are met by the hospice. Section 1861(dd) of the Social Security Act (the Act) establishes PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 71343 distinct criteria for facilities seeking designation as a hospice. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 418 specify the conditions that a hospice must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for hospice services. Generally, to enter into an agreement, a hospice must first be certified by a State survey agency (SA) as complying with the conditions or requirements set forth in part 418. Thereafter, the hospice is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements. However, section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare & Medicaid Services (CMS) approved national Accrediting Organization (AO) that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation. If an AO is recognized by the Secretary of the Department of Health and Human Services as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body’s approved program would be deemed to meet the Medicare conditions. A national AO applying for approval of its accreditation program under part 488, subpart A, must provide CMS with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of AOs are set forth at §§ 488.4 and 488.5. The regulations at § 488.5(e)(2)(i) require AOs to reapply for continued approval of its accreditation program every 6 years or sooner as determined by CMS. The Joint Commission’s current term of approval for their hospice accreditation program expires June 18, 2021. II. Approval of Deeming Organizations Section 1865(a)(2) of the Act and regulations at § 488.5 require that our findings concerning review and approval of a national AO’s requirements consider, among other factors, the applying AO’s requirements for accreditation; survey procedures; E:\FR\FM\09NON1.SGM 09NON1

Agencies

[Federal Register Volume 85, Number 217 (Monday, November 9, 2020)]
[Notices]
[Pages 71340-71343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24813]


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FEDERAL TRADE COMMISSION

[File No. 201-0014]


Stryker and Wright Medical; Analysis of Consent Orders To Aid 
Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement; request for comment.

-----------------------------------------------------------------------

SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair methods of competition. 
The attached Analysis to Aid Public Comment describes both the 
allegations in the complaint and the terms of the consent order--
embodied in the consent agreement--that would settle these allegations.

DATES: Comments must be received on or before December 9, 2020.

ADDRESSES: Interested parties may file comments online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write: ``Stryker and Wright 
Medical; File No. 201 0014'' on your comment, and file your comment 
online at https://www.regulations.gov by following the instructions on 
the web-based form. If you prefer to file your comment on paper, please 
mail your

[[Page 71341]]

comment to the following address: Federal Trade Commission, Office of 
the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), 
Washington, DC 20580; or deliver your comment to the following address: 
Federal Trade Commission, Office of the Secretary, Constitution Center, 
400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 
20024.

FOR FURTHER INFORMATION CONTACT: Jonathan Ripa (202-326-2230), Bureau 
of Competition, Federal Trade Commission, 600 Pennsylvania Avenue NW, 
Washington, DC 20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, 
notice is hereby given that the above-captioned consent agreement 
containing a consent order to cease and desist, having been filed with 
and accepted, subject to final approval, by the Commission, has been 
placed on the public record for a period of thirty (30) days. The 
following Analysis of Agreement Containing Consent Orders to Aid Public 
Comment describes the terms of the consent agreement and the 
allegations in the complaint. An electronic copy of the full text of 
the consent agreement package can be obtained from the FTC website at 
this web address: https://www.ftc.gov/news-events/commission-actions.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before December 9, 
2020. Write ``Stryker and Wright Medical; File No. 201 0014'' on your 
comment. Your comment--including your name and your state--will be 
placed on the public record of this proceeding, including, to the 
extent practicable, on the https://www.regulations.gov website.
    Due to the public health emergency in response to the COVID-19 
outbreak and the agency's heightened security screening, postal mail 
addressed to the Commission will be subject to delay. We strongly 
encourage you to submit your comments online through the https://www.regulations.gov website.
    If you prefer to file your comment on paper, write ``Stryker and 
Wright Medical; File No. 201 0014'' on your comment and on the 
envelope, and mail your comment to the following address: Federal Trade 
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite 
CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex 
D), Washington, DC 20024. If possible, submit your paper comment to the 
Commission by courier or overnight service.
    Because your comment will be placed on the publicly accessible 
website at https://www.regulations.gov, you are solely responsible for 
making sure that your comment does not include any sensitive or 
confidential information. In particular, your comment should not 
include sensitive personal information, such as your or anyone else's 
Social Security number; date of birth; driver's license number or other 
state identification number, or foreign country equivalent; passport 
number; financial account number; or credit or debit card number. You 
are also solely responsible for making sure your comment does not 
include sensitive health information, such as medical records or other 
individually identifiable health information. In addition, your comment 
should not include any ``trade secret or any commercial or financial 
information which . . . is privileged or confidential''--as provided by 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 
16 CFR 4.10(a)(2)--including in particular competitively sensitive 
information such as costs, sales statistics, inventories, formulas, 
patterns, devices, manufacturing processes, or customer names.
    Comments containing material for which confidential treatment is 
requested must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request, and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted on https://www.regulations.gov--as legally required by FTC 
Rule 4.9(b)--we cannot redact or remove your comment from that website, 
unless you submit a confidentiality request that meets the requirements 
for such treatment under FTC Rule 4.9(c), and the General Counsel 
grants that request.
    Visit the FTC website at http://www.ftc.gov to read this Notice and 
the news release describing this matter. The FTC Act and other laws 
that the Commission administers permit the collection of public 
comments to consider and use in this proceeding, as appropriate. The 
Commission will consider all timely and responsive public comments that 
it receives on or before December 9, 2020. For information on the 
Commission's privacy policy, including routine uses permitted by the 
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

Analysis of Consent Orders To Aid Public Comment

I. Introduction

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from Stryker Corporation (``Stryker'') designed to remedy 
the anticompetitive effects resulting from Stryker's proposed 
acquisition of Wright Medical Group N.V. (``Wright''). The proposed 
Decision and Order (``Order'') contained in the Consent Agreement 
requires Stryker to divest all rights and assets related to its total 
ankle replacement and finger joint implant businesses to DJO Global, 
Inc. (``DJO'').
    The proposed Consent Agreement has been placed on the public record 
for thirty days for receipt of comments from interested persons. 
Comments received during this period will become part of the public 
record. After thirty days, the Commission will review the comments 
received and decide whether it should withdraw, modify, or make the 
Consent Agreement final.
    Under the terms of the Purchase Agreement dated November 4, 2019, 
Stryker will acquire all of the outstanding shares of Wright for a 
total equity value of approximately $4 billion (``the Acquisition''). 
The Commission's Complaint alleges that the proposed Acquisition, if 
consummated, would violate Section 7 of the Clayton Act, as amended, 15 
U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as 
amended, 15 U.S.C. 45, by substantially lessening competition in the 
U.S. markets for total ankle replacements and finger joint implants. 
The proposed Consent Agreement would remedy the alleged violations by 
preserving the competition that otherwise would be lost in these 
markets as a result of the proposed Acquisition.

II. The Parties

    Stryker is a global medical device company based in Kalamazoo, 
Michigan. Stryker organizes its business operations into three 
segments: Orthopedics; medical and surgical; and neurotechnology and 
spine.
    Headquartered in Amsterdam, the Netherlands, Wright is a global 
medical device company focused on extremities

[[Page 71342]]

and biologics products. Wright divides its business into four 
categories: Upper extremities; lower extremities; biologics products; 
and sports medicine.

III. The Relevant Products and Market Structures

a. Total Ankle Replacements

    Total ankle replacements are used to treat end-stage ankle 
arthritis, in which the cartilage on the tibia (shin), talus (top of 
the foot), and fibula (calf) bones that form the ankle joint has worn 
away to create bone-on-bone grinding. Patients with end-stage ankle 
arthritis--typically aged fifty and older--experience severe pain and 
swelling of the ankle along with difficulty walking. Total ankle 
replacements reduce pain while maintaining, and even increasing, ankle 
motion. In a total ankle replacement procedure, a surgeon removes 
damaged portions of bone and cartilage and replaces it with a three-
piece system. A metal tibial tray, a metal talar dome, and a plastic 
insert (polyethylene bearing) mimic the cartilage in the joint. In a 
fixed bearing total ankle replacement, the polyethylene bearing is 
locked to the tibial component, while in a mobile bearing system it 
moves independently. Physicians and their patients would not switch to 
an alternative product or therapy in response to a small but 
significant increase in the price of total ankle replacements.
    Wright and Stryker are the first and third-largest suppliers in the 
United States, respectively, of total ankle replacements, while Integra 
LifeSciences (``Integra'') is the second-largest supplier. Exactech, 
Inc. and Zimmer Biomet also supply total ankle replacement products but 
have only small shares of the U.S. ankle replacement market. Together, 
Stryker and Wright would account for approximately 75 percent of the 
market.

b. Finger Joint Implants

    Finger joint implants are used to treat advanced osteoarthritis and 
are implanted into a patient's proximal interphalangeal joints or 
metacarpophalangeal joints through a surgical procedure to replace 
damaged bone and cartilage. Arthritis is a gradual, progressive 
condition typically treated in stages. Physicians seek to use the least 
invasive treatment option possible to meet each patient's needs, using 
finger joint implants only when all other options have failed. 
Physicians and their patients would not switch to an alternative 
product or therapy in response to a small but significant increase in 
the price of finger joint implants.
    Stryker and Wright are two of only three significant suppliers for 
finger joint implants in the United States. Integra is the leading 
supplier while Stryker and Wright are the second and third-largest 
suppliers, respectively. BioPro Implants (``BioPro'') is the only other 
supplier of finger joint implants in the United States but has a very 
small share of the U.S. finger joint implant market. The combined 
Stryker and Wright would have a market share in the United States in 
excess of 50 percent.

III. The Relevant Geographic Markets

    The United States is the relevant geographic market in which to 
assess the competitive effects of the proposed Acquisition. Total ankle 
replacements and finger joint implants are medical devices regulated by 
the U.S. Food and Drug Administration (``FDA''). As such, total ankle 
replacements and finger joint implants sold outside the United States, 
but not approved for sale in the United States, do not provide viable 
competitive alternatives for U.S. consumers.

IV. Competitive Effects of the Acquisition

    The proposed Acquisition would likely result in substantial 
competitive harm to consumers in the markets for total ankle 
replacements and finger joint implants. As suppliers of close 
substitutes in each relevant market, Stryker and Wright respond 
directly to competition from each other with improved products, better 
service, and lower prices. By eliminating this direct and substantial 
head-to-head competition, the proposed Acquisition likely would allow 
the combined firm to exercise market power unilaterally, resulting in 
less innovation and higher prices for consumers.

V. Entry Conditions

    Entry in the relevant markets would not be timely, likely, or 
sufficient in magnitude, character, and scope to deter or counteract 
the anticompetitive effects of the proposed Acquisition. To enter or 
effectively expand in either relevant market successfully, a supplier 
would need to design and manufacture an effective product, obtain FDA 
approval, and develop clinical history supporting the long-term 
efficacy of its product. The new entrant or expanding firm would also 
need to develop and foster product loyalty and establish a nationwide 
sales network capable of marketing the product and providing on-site 
service at hospitals nationwide. Establishing a track record for 
quality, service, and consistency is difficult, expensive, and 
typically requires several years.

VI. The Consent Agreement

    The Consent Agreement eliminates the competitive concerns raised by 
the proposed Acquisition by requiring the parties to divest to DJO all 
of the rights and assets needed for it to become an independent, 
viable, and effective competitor in the U.S. markets for total ankle 
replacements and finger joint implants. The divestitures will maintain 
the competition that currently exists in each of the relevant markets.
    DJO is well positioned to restore the competition that otherwise 
would be lost through the proposed Acquisition. Headquartered in Vista, 
California, DJO is a global medical device company that has experience 
manufacturing, marketing, and distributing orthopedic devices in the 
United States, and a track record for quality, service, and 
consistency. DJO's lower and upper extremity product portfolio is also 
highly complementary to Stryker's total ankle replacements and finger 
joint implants.
    The Order requires Stryker to divest all assets related to the 
divested businesses other than real property and tangible personal 
property. The divested assets include all inventory, contracts, 
permits, intellectual property (``IP''), and business information 
related to Stryker's total ankle replacement and finger joint implant 
products. Certain IP, which Stryker uses for both the divested products 
as well as retained products, will be retained by Stryker and licensed 
to DJO.
    To ensure continuity for customers, the Order requires that Stryker 
supply DJO with transition assistance sufficient to efficiently 
transfer the total ankle replacement and finger joint implant assets to 
DJO and to assist DJO in operating the assets and business, in all 
material respects, in the manner in which Stryker did prior to the 
proposed Acquisition. Until DJO obtains FDA approval to become the 
legal manufacturer of the products, Stryker will act as an intermediary 
supplier for DJO. Further, the Order requires that the parties transfer 
all confidential business information to DJO, as well as provide access 
to employees who possess or are able to identify such information. DJO 
also will have the right to interview and offer employment to employees 
associated with the relevant products.
    The parties must accomplish these divestitures and relinquish their 
rights to DJO no later than ten days after the proposed Acquisition is 
consummated.

[[Page 71343]]

If the Commission determines that DJO is not an acceptable acquirer, or 
that the manner of the divestitures is not acceptable, the proposed 
Order requires the parties to unwind the sale of rights to DJO and then 
divest the products to a Commission-approved acquirer within six months 
of the date the Order becomes final. The proposed Order further allows 
the Commission to appoint a trustee in the event the parties fail to 
divest the products as required.
    The Order also requires the parties to appoint Justin Menezes, from 
Mazars, as interim monitor to ensure the parties comply with the 
obligations pursuant to the Consent Agreement and to keep the 
Commission informed about the status of the transfer of the assets and 
rights to DJO.
    The purpose of this analysis is to facilitate public comment on the 
Consent Agreement, and it is not intended to constitute an official 
interpretation of the proposed Order or to modify its terms in any way.

    By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2020-24813 Filed 11-6-20; 8:45 am]
BILLING CODE 6750-01-P