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.
Cleared Devices (92)
| 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 |
| K042093 | VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS | Biomet, Inc. | Nov 1, 2004 | SESE |
| K040889 | EXACTECH OPTETRAK UNICONDYLAR KNEE | Exactech, Inc. | Oct 1, 2004 | SESE |
| K040268 | DEPUY PRESERVATION UNICONDYLAR TIBIA | DePuy Orthopaedics, Inc. | May 5, 2004 | SESE |
| K033351 | GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE | Global Orthopaedic Technology, USA, Inc. | Mar 11, 2004 | SESE |
| K033810 | NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM | Centerpulse Orthopedics, Inc. | Mar 5, 2004 | SESE |
| K032052 | UC-PLUS SOLUTION UNICONDYLAR KNEE | Plus Orthopedics | Jul 25, 2003 | SESE |
| K030446 | REPICCI LOCKED KEEL TIBIAL BEARING | Biomet, Inc. | Mar 6, 2003 | SESE |
| K030193 | ADVANCE LESS CONFORMING TIBIAL COMPONENT | Wrightmedicaltechnologyinc | Feb 20, 2003 | SESE |
| K022437 | UNI KNEE | Encore Medical L.P. | Aug 23, 2002 | SESE |
| K021621 | FIXED BEARING UNI COMPONENT | Biomet, Inc. | Jun 5, 2002 | SESE |
| K020741 | UNICONDYLAR KNEE | Encore Orthopedics, Inc. | Jun 4, 2002 | SESE |
| K012800 | SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM | Whiteside Biomechanics, Inc. | May 3, 2002 | SESE |
| K014171 | ADVANCE UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | Mar 15, 2002 | SESE |
| K020264 | REPICCI II UNICONDYLAR KNEE SYSTEM | Biomet Orthopedics, Inc. | Feb 8, 2002 | SESE |
| K012762 | MJS POSTERIOR STABILIZED KNEE SYSTEM | Osteoimplant Technology, Inc. | Dec 11, 2001 | SESE |
| K012591 | ADVANCE UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | Nov 2, 2001 | SESE |
| K011138 | OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT | Biomet, Inc. | Jul 10, 2001 | SESE |
| K011795 | WORLAND UNICONDYLAR TIBIAL BEARING | Biomet, Inc. | Jun 13, 2001 | SESE |
| K011509 | BARRETT UNICONDYLAR TIBIAL BEARING | Biomet, Inc. | Jun 13, 2001 | SESE |
| K010810 | DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS | DePuy Orthopaedics, Inc. | Apr 18, 2001 | SESE |
| K001451 | MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS | DePuy Orthopaedics, Inc. | May 18, 2000 | SESE |
| K983657 | OSTEONICS SERIES 7000 AD TIBIAL TRAY | Osteonics Corp. | Apr 6, 2000 | SESE |
| K000172 | DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS | DePuy Orthopaedics, Inc. | Feb 3, 2000 | SESE |
| K982859 | UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM | Plus Orthopedics | Jul 30, 1999 | SESE |
| K980665 | REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS | Biomet, Inc. | May 20, 1998 | SESE |
| K974434 | OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS | Osteonics Corp. | Jan 12, 1998 | SN |
| K971938 | REPICCI II UNICONDYLAR KNEE | Biomet, Inc. | Aug 25, 1997 | SESE |
| K954481 | P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM | Johnson & Johnson Professionals, Inc. | Oct 10, 1996 | SESE |
| K961900 | TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM | Wrightmedicaltechnologyinc | Jul 25, 1996 | SESE |
| K960617 | ADVANCE TIBIAL COMPONENT | Wrightmedicaltechnologyinc | May 8, 1996 | SN |
| K955778 | NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM | Intermedics Orthopedics | Mar 8, 1996 | SN |
| K944538 | GAS PLASMA STERILIZATION | Depuy, Inc. | Sep 26, 1995 | SESE |
| K940389 | S.T.E.P. UNI-KNEE | S.T.E.P. Orthopaedics, Inc. | Jan 19, 1995 | SN |
| K933935 | CKS POROUS COATED FEMORAL COMPONENT | Techmedica, Inc. | Oct 11, 1994 | SESE |
| K923011 | OSTEONICS UNIX UNICOMPARTMENTAL | Osteonics Corp. | Nov 30, 1993 | SESE |
| K910968 | P.F.C. UNICONDYLAR KNEE SYSTEM | Johnson & Johnson Orthopaedics, Inc. | Aug 26, 1991 | SESE |
| K911373 | OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP | Osteonics Corp. | Jun 26, 1991 | SESE |
| K902538 | WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION | Dow Corning Wright | Jul 6, 1990 | SN |
| K890044 | BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE | Biopro, Inc. | Nov 6, 1989 | SN |
| K883969 | UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM | Intermedics Orthopedics | Apr 19, 1989 | SN |
| K884837 | KINEMAX TIBIAL WEDGE | Howmedica Corp. | Feb 17, 1989 | SESE |
| P840049 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. | Sep 30, 1988 | APWD |
| K882241 | KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM | Kirschner Medical Corp. | Jun 29, 1988 | SESE |
| K873601 | AGC UNICOMPARTMENTAL KNEE PROSTHESIS | Biomet, Inc. | Jan 20, 1988 | SESE |
| K864070 | WHITESIDE ORTHOLOC (TM) | Dow Corning Wright | Jan 27, 1987 | SN |
| K862125 | ARIZONA CONDYLAR TIBIAL PLATEAU | Depuy, Inc. | Jun 27, 1986 | SESE |
| K860133 | MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU | Depuy, Inc. | Mar 10, 1986 | SN |
| K842367 | HOWMEDICA KINEMATIC II TIBIAL WEDGE | Howmedica Corp. | Aug 17, 1984 | SESE |
| K834298 | UNICONDYLAR FIBER METAL KNEE | Zimmer, Inc. | Feb 13, 1984 | SESE |
| K831143 | P.C.A. UNICOMPARTMENTAL KNEE PROSTHES | Howmedica Corp. | Aug 16, 1983 | SESE |
| K821341 | IOI METAL BACKED TIBIAL COMPONENT | Intermedics Orthopedics | Jun 3, 1982 | SESE |
| K820002 | BARD CONTOUR LINK S.K.I. KNEE SYS | C.R. Bard, Inc. | May 27, 1982 | SESE |
| K820030 | HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE | Howmedica Corp. | Feb 5, 1982 | SESE |
| K812012 | TOWNLEY UNICONDYLAR KNEE | Depuy, Inc. | Sep 24, 1981 | SESE |
| K810540 | KNEE PROSTHESIS | Cintor Orthopaedic Div. | Apr 7, 1981 | SESE |
| K810060 | P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH | Howmedica Corp. | Apr 7, 1981 | SESE |
| K810616 | MILLER MULTI-RADIUS TOTAL KNEE | Zimmer, Inc. | Mar 20, 1981 | SESE |
| K810230 | CONDYLAR KNEE W/METAL ENCAPSULATED TIB | Hexcel Medical | Mar 6, 1981 | SESE |
| K802446 | RANAWAT ESF TOTAL CONDYLAR KNEE | Howmedica Corp. | Oct 31, 1980 | SESE |
| K792619 | RMC KNEE METAL SHOE TIBIAL COMPONENTS | Richard'S Medical Equip., Inc. | Feb 5, 1980 | SESE |
| K792325 | LIVERPOOL KNEE PROSTHESIS | Downs Surgical , Ltd. | Jan 21, 1980 | SESE |
| K790762 | PLATFORM TCCK TOTAL KNEE | Biomet, Inc. | May 14, 1979 | SESE |
| K790350 | POSTERIOR CRUCIATE CONDYLAR TIBIAL | Howmedica Corp. | Mar 6, 1979 | SESE |
| K790349 | TOTAL CONDYLAR KNEE PROSTHESIS | Howmedica Corp. | Mar 6, 1979 | SESE |
| K790348 | ANAMETRIC TIBIAL COMPONENT METAL TRAY | Howmedica Corp. | Mar 6, 1979 | SESE |
| K781608 | CENTRAL PEG TIBIAL COMPONENT | Howmedica Corp. | Sep 27, 1978 | SESE |
| K780299 | TOTAL KNEE SYSTEM | Richard'S Medical Equip., Inc. | Apr 27, 1978 | SESE |
| K761278 | TOTAL TIBIAL KNEE | Depuy, Inc. | Jan 5, 1977 | SESE |
| K760842 | GEOMEDIC ANAMETRIC TOTAL KNEE | Howmedica Corp. | Oct 20, 1976 | SESE |
| K760744 | TAVERNETTI-TENNANT | Cutter Laboratories, Inc. | Oct 7, 1976 | SESE |
| K760334 | PROSTEHSIS, TOTAL KNEE REPLACEMENT | Depuy, Inc. | Aug 11, 1976 | SESE |
| K760245 | PROSTHESIS, RICHARDS MOD II KNEE | Richard'S Medical Equip., Inc. | Jul 26, 1976 | SESE |
Top Applicants
- Howmedica Corp. — 12 clearances
- Biomet, Inc. — 10 clearances
- Wrightmedicaltechnologyinc — 6 clearances
- Depuy, Inc. — 6 clearances
- DePuy Orthopaedics, Inc. — 5 clearances
