Panels › Orthopedic › Product code HSX · Class 2
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation 888.3520
3510(k)s in 12 months (115 all time)
0recalls in 12 months (104 all time)
100recalls that name a 510(k)
Top companies in HSX
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 13 | 54 |
| Linkbio Corp. | 0 | 32 |
| Conformis, Inc. | 8 | 3 |
| Zimmer, Inc. | 9 | 2 |
| Bodycad Laboratories, Inc. | 7 | 0 |
| Mako Surgical Corp. | 6 | 0 |
| Zimmer Biomet | 1 | 5 |
| Depuy, Inc. | 5 | 0 |
| Howmedica Corp. | 5 | 0 |
| Medacta International S.A. | 5 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 5, 2010 | K102069 | JOURNEY UNICONDYLAR TIBIAL BASEPLATES Smith & Nephew, Inc. | HSX |
| Jul 23, 2010 | K101206 | TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM Alexandria Research Technologies, LLC | HSX |
| Feb 19, 2010 | K100197 | GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS Smith & Nephew, Inc. | HSX |
| Sep 9, 2009 | K092441 | MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM Conformis, Inc. | HSX |
| May 4, 2009 | K090024 | TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM Alexandria Research Technologies, LLC | HSX |
| Nov 28, 2008 | K082172 | MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM Mako Surgical Corporation | HSX |
| Oct 15, 2008 | K082081 | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III Mako Surgical Corp. | HSX |
| Jul 24, 2008 | K081351 | MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT Smith & Nephew, Inc. | HSX |
| Jun 20, 2008 | K080368 | MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II Mako Surgical Corp. | HSX |
| Dec 20, 2007 | K073175 | JOURNEY UNICONDYLAR FEMORAL IMPLANT Smith & Nephew, Inc. | HSX |
| Dec 12, 2007 | K073248 | MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM Mako Surgical Corp. | HSX |
| Nov 8, 2007 | K072586 | CONFORMIS UNI-CONDYLAR KNEE SYSTEM Conformis, Inc. | HSX |
| Sep 20, 2007 | K072368 | CONFORMIS METAL BACKED TIBIAL COMPONENT Conformis, Inc. | HSX |
| Mar 16, 2007 | K063432 | CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) Conformis, Inc. | HSX |
| Jan 19, 2007 | K063782 | ACCIN UNI-KNEE SYSTEM Accin Corporation | HSX |
| Aug 4, 2006 | K061779 | COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE Smith & Nephew, Inc. | HSX |
| Jul 11, 2006 | K061011 | COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE Smith & Nephew, Inc. | HSX |
| Jun 2, 2006 | K060670 | ACCIN UNI-KNEE SYSTEM Accin Corporation | HSX |
| Feb 23, 2006 | K060017 | MAKO SURGICAL UNICONDYLAR KNEE SYSTEM Mako Surgical Corp. | HSX |
| Oct 11, 2005 | K050373 | UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS Arthrosurface, Inc. | HSX |
| Mar 14, 2005 | K043570 | UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD Conformis, Inc. | HSX |
| Feb 13, 2004 | K033769 | EIUS UNICOMPARTMENTAL KNEE SYSTEM Howmedica Osteonics Corp. | HSX |
| Jan 16, 2004 | K033363 | ZIMMER UNICOMPARTMENTAL KNEE SYSTEM Zimmer, Inc. | HSX |
| Nov 13, 2003 | K032824 | STELKAST UNICONDYLAR KNEE SYSTEM Stelkast Company | HSX |
| May 22, 2003 | K022211 | HLS UNI EVOLUTION PROSTHESIS Tornier, FR | HSX |
| Sep 19, 2001 | K011954 | SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE Sulzer Orthopedics, Inc. | HSX |
| Apr 2, 2001 | K010685 | MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) Zimmer, Inc. | HSX |
| Nov 16, 1999 | K992287 | FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM Howmedica Osteonics Corp. | HSX |
| Jan 26, 1996 | K954186 | SLED UNICOMPARTMENT KNEE SYSTEM Link America, Inc. | HSX |
| Sep 19, 1995 | K952068 | ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES Zimmer, Inc. | HSX |
| Jul 11, 1995 | K942263 | MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM Zimmer, Inc. | HSX |
| Mar 6, 1995 | K945613 | DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT Howmedica Corp. | HSX |
| Oct 14, 1994 | K941606 | PRESERVATION UNICOMPARTMENTAL KNEE Depuy, Inc. | HSX |
| Feb 15, 1994 | K931214 | P.C.A. MODULAR KNEE SYSTEM Howmedica Corp. | HSX |
| Mar 30, 1993 | K926231 | DURACON UNICOMPARTMENTAL KNEE SYSTEM Howmedica Corp. | HSX |
| Sep 17, 1992 | K922824 | KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM Joint Medical Products Corp. | HSX |
| Jun 9, 1992 | K921232 | KEANE UNI KNEE SYSTEM WITH POROCOAT Depuy, Inc. | HSX |
| Jan 31, 1992 | K915240 | NATURAL-KNEE TIBIAL AND FEMORAL SPACERS Intermedics Orthopedics | HSX |
| Dec 27, 1991 | K912735 | GENESIS UNICOMPARTMENTAL KNEE SYSTEM Smith & Nephew Richards, Inc. | HSX |
| Oct 23, 1991 | K914439 | P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL Johnson & Johnson Orthopaedics, Inc. | HSX |
| Jun 27, 1991 | K910807 | KEANE UNI KNEE SYSTEM Depuy, Inc. | HSX |
| Apr 1, 1991 | K910083 | OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES Osteonics Corp. | HSX |
| Oct 12, 1990 | K903286 | CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION Techmedica, Inc. | HSX |
| Jun 11, 1990 | K900619 | CAAS UNICOMPARMENTAL KNEE SYSTEM Techmedica, Inc. | HSX |
| Jun 5, 1990 | K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM Concept, Inc. | HSX |
| Feb 6, 1990 | K896856 | MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS Osteonics Corp. | HSX |
| Dec 8, 1989 | K894068 | KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM Kirschner Medical Corp. | HSX |
| Aug 31, 1988 | K881779 | WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM Dow Corning Wright | HSX |
| Aug 3, 1988 | K880155 | MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE Zimmer, Inc. | HSX |
| Dec 31, 1987 | K873970 | KIRSCHNER UNICONDYLAR KNEE SYSTEM Kirschner Medical Corp. | HSX |
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