HRY · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Orthopedic · 21 CFR 888.3530 · Class 2
Overview
| Product Code | HRY |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Regulation | 21 CFR 888.3530 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 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 | SIGMA High Performance (HP) Partial Knee System | Depuy Ireland UC | Apr 16, 2020 | SESE |
| K190633 | NanoOrtho NanoKnee® System | Nanoortho, LLC | Dec 20, 2019 | SESE |
| K152631 | MPO Total Knee Systems MR Labeling | Microport Orthopedics, Inc. | Mar 23, 2016 | SESE |
| K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corporation | Mar 20, 2015 | SESE |
| K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | Biomet UK, Ltd. | Mar 28, 2014 | SESE |
| K131167 | UNIVATION | Aesculap Implant Systems, LLC | Oct 17, 2013 | SESE |
| K122277 | 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 | SIGNATURE PLANNER / SIGNATURE GUIDES | Materialise NV | May 16, 2011 | SESE |
| K100973 | EVOLUTION UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | Aug 10, 2010 | SESE |
| K082567 | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION | Howmedica Osteonics Corp. | Oct 3, 2008 | SESE |
| K081293 | UNIVATION UNICONDYLAR KNEE SYSTEM | Aesculap Implant Systems, Inc. | Sep 22, 2008 | SESE |
| K072704 | UNICOMPARTMENTAL KNEE | Valpo Orthopedic Technology, Inc. | Feb 19, 2008 | SESE |
| K071881 | TRIATHLON PKR SYSTEM | Howmedica Osteonics Corp. | Oct 9, 2007 | SESE |
| K070267 | DEPUY GCK TIBIAL COMPONENTS | DePuy Orthopaedics, Inc. | Aug 17, 2007 | SESE |
| K063515 | TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE | Biomet Manufacturing, Inc. | Feb 2, 2007 | SESE |
| K061681 | REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT | Biomet Manufacturing Corp | Oct 19, 2006 | SESE |
| K060412 | ACTIVE UNICOMPARTMENTAL KNEE SYSTEM | Australian Surgical Design & Manufacture | May 17, 2006 | SESE |
| K053299 | REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT | Biomet Manufacturing, Inc. | Jan 5, 2006 | SESE |
| K051721 | GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM | Global Orthopaedic Technology, USA, Inc. | Oct 26, 2005 | SESE |
| K050764 | 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
