Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3530](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3530) → HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer # HRY · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer _Orthopedic · 21 CFR 888.3530 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY ## Overview - **Product Code:** HRY - **Device Name:** Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer - **Regulation:** [21 CFR 888.3530](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3530) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 92) Showing 20 most recent of 92 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K193549](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K193549.md) | SIGMA High Performance (HP) Partial Knee System | Depuy Ireland UC | Apr 16, 2020 | SESE | | [K190633](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K190633.md) | NanoOrtho NanoKnee® System | Nanoortho, LLC | Dec 20, 2019 | SESE | | [K152631](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K152631.md) | MPO Total Knee Systems MR Labeling | Microport Orthopedics, Inc. | Mar 23, 2016 | SESE | | [K150410](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K150410.md) | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corporation | Mar 20, 2015 | SESE | | [K133940](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K133940.md) | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | Biomet UK, Ltd. | Mar 28, 2014 | SESE | | [K131167](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K131167.md) | UNIVATION | Aesculap Implant Systems, LLC | Oct 17, 2013 | SESE | | [K122277](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K122277.md) | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM | Biomet Manufacturing Corp | Oct 22, 2012 | SESE | | [K110415](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K110415.md) | SIGNATURE PLANNER / SIGNATURE GUIDES | Materialise NV | May 16, 2011 | SESE | | [K100973](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K100973.md) | EVOLUTION UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | Aug 10, 2010 | SESE | | [K082567](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K082567.md) | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION | Howmedica Osteonics Corp. | Oct 3, 2008 | SESE | | [K081293](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K081293.md) | UNIVATION UNICONDYLAR KNEE SYSTEM | Aesculap Implant Systems, Inc. | Sep 22, 2008 | SESE | | [K072704](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K072704.md) | UNICOMPARTMENTAL KNEE | Valpo Orthopedic Technology, Inc. | Feb 19, 2008 | SESE | | [K071881](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K071881.md) | TRIATHLON PKR SYSTEM | Howmedica Osteonics Corp. | Oct 9, 2007 | SESE | | [K070267](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K070267.md) | DEPUY GCK TIBIAL COMPONENTS | DePuy Orthopaedics, Inc. | Aug 17, 2007 | SESE | | [K063515](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K063515.md) | TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE | Biomet Manufacturing, Inc. | Feb 2, 2007 | SESE | | [K061681](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K061681.md) | REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT | Biomet Manufacturing Corp | Oct 19, 2006 | SESE | | [K060412](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K060412.md) | ACTIVE UNICOMPARTMENTAL KNEE SYSTEM | Australian Surgical Design & Manufacture | May 17, 2006 | SESE | | [K053299](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K053299.md) | REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT | Biomet Manufacturing, Inc. | Jan 5, 2006 | SESE | | [K051721](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K051721.md) | GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM | Global Orthopaedic Technology, USA, Inc. | Oct 26, 2005 | SESE | | [K050764](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K050764.md) | UNIGLIDE UNICONDYLAR KNEE PROSTHESIS | Corin USA | Aug 24, 2005 | SESE | ## Top Applicants - Howmedica Corp. — 12 clearances - Biomet, Inc. — 10 clearances - Depuy, Inc. — 6 clearances - Wrightmedicaltechnologyinc — 6 clearances - DePuy Orthopaedics, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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