Attune Revision LPS Inserts

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October 8, 2019 Depuy (Ireland) % Soraya Hori Sr. Regulatory Affairs Associate Depuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Re: K191779 Trade/Device Name: Attune Revision LPS Inserts Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO Dated: July 1, 2019 Received: July 2, 2019 Dear Soraya Hori: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Ting Song Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K191779 Device Name ATTUNE® Revision LPSTM Inserts #### Indications for Use (Describe) The ATTUNE Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: · malignant tumors (e.g., osteosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; · patient conditions of non-inflammatory degenerative joint disease (NIDJ), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; · revision cases for a failed previous prosthesis requiring extensive resection and replacement; · severe trauma requiring extensive resection and replacement. · post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary (As required by 21 CFR 807.92 and 21 CFR 807.93) | Submitter Information | | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | DePuy Orthopaedics, Inc. | | Address | 700 Orthopaedic Drive | | | Warsaw, IN 46582 | | Phone number | 574-372-7491 | | Fax number | 574- 371-4987 | | Establishment Registration<br>Number | 1818910 | | Name of contact person | Soraya L. Hori | | Date prepared | July 1, 2019 | | Name of device | | | Trade or proprietary name | ATTUNE® Revision LPSTM Inserts | | Common or usual name | Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer | | Classification name | Knee joint femorotibial metal/polymer constrained cemented prosthesis | | Class | II | | Classification panel | 87 Orthopedics | | Regulation | 21 CFR 888.3510 | | Product Code(s) | KRO | | Legally marketed device(s) | Primary: LPS Universal Hinge Tibial Inserts, K091453 | | to which equivalence is<br>claimed | Secondary: ATTUNE Knee System AOX Tibial Inserts, K101433,<br>K111433, K160700 | | Device description | The ATTUNE Revision LPS Inserts are designed to replace the tibio-<br>femoral articular surface of the knee joint when used in conjunction with<br>a femoral, tibial, patellar, and other associated prostheses as required.<br>The ATTUNE Revision LPS Insert consists of an AOX™ Antioxidant<br>Polyethylene bearing, AOX Antioxidant Polyethylene bushings, and a<br>forged cobalt chrome molybdenum hinge post. | | Intended Use and<br>Indications for use: | The ATTUNE Revision LPS Insert is intended for use in prosthetic<br>constructs for replacement of distal and/or total femur and resurfacing of<br>the proximal tibia, especially in cases that require extensive resection<br>and replacement. Specific diagnostic indications for use include:<br>malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell<br>tumors, bone tumors) requiring extensive resection and<br>replacement;patient conditions of non-inflammatory degenerative joint disease<br>(NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory | | | joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; | | • | revision cases for a failed previous prosthesis requiring extensive resection and replacement; | | • | severe trauma requiring extensive resection and replacement. | | • | post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required. | {4}------------------------------------------------ ## Summary of Technologies / Substantial Equivalence Discussion: The subject ATTUNE Revision LPS Insert has the same intended use, indications, manufacturing and sterilization methods as the previously cleared LPS Universal Hinge Tibial Inserts (K091453). The subject ATTUNE Revision LPS Insert has the same intended use, materials, biocompatibility, packaging configurations, and sterilization methods as the previously cleared ATTUNE Knee System AOX Tibial Inserts (K101433, K111433, K160700). The testing provided below was used to support equivalence to the predicate devices. | Non-Clinical<br>Testing | Functional testing was conducted in compliance with FDA Guidance, Class II Special<br>Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial<br>Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and<br>FDA, to verify that the implant performance is substantially equivalent to predicate<br>devices for anticipated in-vivo loading with the following tests:<br>• Anterior/Posterior (A/P) Shear Fatigue Verification Test<br>• Insert Subluxation Verification Test<br>• Hinge Post Disassembly Test<br>• Hinge Post Fatigue Verification Test<br>• Hinge Post Assembly Test<br>• Hinge Post Micromotion Test<br>The subject devices also meet the requirement of:<br>• Bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. | |--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clinical<br>Testing: | Clinical testing was not necessary to determine substantial equivalence between the<br>subject and predicate devices. | | Conclusions<br>drawn from<br>Clinical and<br>Non-clinical<br>data: | The subject ATTUNE Revision LPS Insert is substantially equivalent to the predicate<br>LPS Universal Hinge Tibial Inserts and ATTUNE Knee System AOX Tibial Inserts<br>regarding intended use, overall indications, design features, materials, sterilization, and<br>manufacturing.<br>Clinical data and conclusions were not needed for this device. |