FDA Product Code
FDA Product Code HRY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3530
510(k) Clearances — 91 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193549 | SIGMA High Performance (HP) Partial Knee System | Depuy Ireland UC | 2020-04-16 | Traditional | PDF ↗ |
| K190633 | NanoOrtho NanoKnee® System | Nanoortho, LLC | 2019-12-20 | Traditional | PDF ↗ |
| K152631 | MPO Total Knee Systems MR Labeling | Microport Orthopedics, Inc. | 2016-03-23 | Traditional | PDF ↗ |
| K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corporation | 2015-03-20 | Special | PDF ↗ |
| K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | Biomet UK, Ltd. | 2014-03-28 | Traditional | PDF ↗ |
| K131167 | UNIVATION | Aesculap Implant Systems, LLC | 2013-10-17 | Traditional | PDF ↗ |
| K122277 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM | Biomet Manufacturing Corp | 2012-10-22 | Traditional | PDF ↗ |
| K110415 | SIGNATURE PLANNER / SIGNATURE GUIDES | Materialise NV | 2011-05-16 | Traditional | PDF ↗ |
| K100973 | EVOLUTION UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | 2010-08-10 | Traditional | PDF ↗ |
| K082567 | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION | Howmedica Osteonics Corp. | 2008-10-03 | Special | PDF ↗ |
| K081293 | UNIVATION UNICONDYLAR KNEE SYSTEM | Aesculap Implant Systems, Inc. | 2008-09-22 | Traditional | PDF ↗ |
| K072704 | UNICOMPARTMENTAL KNEE | Valpo Orthopedic Technology, Inc. | 2008-02-19 | Traditional | PDF ↗ |
| K071881 | TRIATHLON PKR SYSTEM | Howmedica Osteonics Corp. | 2007-10-09 | Traditional | PDF ↗ |
| K070267 | DEPUY GCK TIBIAL COMPONENTS | DePuy Orthopaedics, Inc. | 2007-08-17 | Traditional | PDF ↗ |
| K063515 | TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE | Biomet Manufacturing, Inc. | 2007-02-02 | Traditional | PDF ↗ |
| K061681 | REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT | Biomet Manufacturing Corp | 2006-10-19 | Traditional | PDF ↗ |
| K060412 | ACTIVE UNICOMPARTMENTAL KNEE SYSTEM | Australian Surgical Design & Manufacture | 2006-05-17 | Traditional | PDF ↗ |
| K053299 | REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT | Biomet Manufacturing, Inc. | 2006-01-05 | Traditional | PDF ↗ |
| K051721 | GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM | Global Orthopaedic Technology, USA, Inc. | 2005-10-26 | Traditional | PDF ↗ |
| K050764 | UNIGLIDE UNICONDYLAR KNEE PROSTHESIS | Corin USA | 2005-08-24 | Traditional | PDF ↗ |
| K042093 | VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS | Biomet, Inc. | 2004-11-01 | Traditional | PDF ↗ |
| K040889 | EXACTECH OPTETRAK UNICONDYLAR KNEE | Exactech, Inc. | 2004-10-01 | Traditional | PDF ↗ |
| K040268 | DEPUY PRESERVATION UNICONDYLAR TIBIA | DePuy Orthopaedics, Inc. | 2004-05-05 | Special | PDF ↗ |
| K033351 | GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE | Global Orthopaedic Technology, USA, Inc. | 2004-03-11 | Traditional | PDF ↗ |
| K033810 | NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM | Centerpulse Orthopedics, Inc. | 2004-03-05 | Traditional | PDF ↗ |
| K032052 | UC-PLUS SOLUTION UNICONDYLAR KNEE | Plus Orthopedics | 2003-07-25 | Special | PDF ↗ |
| K030446 | REPICCI LOCKED KEEL TIBIAL BEARING | Biomet, Inc. | 2003-03-06 | Special | PDF ↗ |
| K030193 | ADVANCE LESS CONFORMING TIBIAL COMPONENT | Wrightmedicaltechnologyinc | 2003-02-20 | Special | PDF ↗ |
| K022437 | UNI KNEE | Encore Medical L.P. | 2002-08-23 | Special | PDF ↗ |
| K021621 | FIXED BEARING UNI COMPONENT | Biomet, Inc. | 2002-06-05 | Special | PDF ↗ |
| K020741 | UNICONDYLAR KNEE | Encore Orthopedics, Inc. | 2002-06-04 | Traditional | PDF ↗ |
| K012800 | SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM | Whiteside Biomechanics, Inc. | 2002-05-03 | Traditional | PDF ↗ |
| K014171 | ADVANCE UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | 2002-03-15 | Traditional | PDF ↗ |
| K020264 | REPICCI II UNICONDYLAR KNEE SYSTEM | Biomet Orthopedics, Inc. | 2002-02-08 | Special | PDF ↗ |
| K012762 | MJS POSTERIOR STABILIZED KNEE SYSTEM | Osteoimplant Technology, Inc. | 2001-12-11 | Traditional | PDF ↗ |
| K012591 | ADVANCE UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | 2001-11-02 | Abbreviated | PDF ↗ |
| K011138 | OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT | Biomet, Inc. | 2001-07-10 | Traditional | PDF ↗ |
| K011509 | BARRETT UNICONDYLAR TIBIAL BEARING | Biomet, Inc. | 2001-06-13 | Special | PDF ↗ |
| K011795 | WORLAND UNICONDYLAR TIBIAL BEARING | Biomet, Inc. | 2001-06-13 | Special | PDF ↗ |
| K010810 | DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS | DePuy Orthopaedics, Inc. | 2001-04-18 | Special | PDF ↗ |
| K001451 | MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS | DePuy Orthopaedics, Inc. | 2000-05-18 | Special | PDF ↗ |
| K983657 | OSTEONICS SERIES 7000 AD TIBIAL TRAY | Osteonics Corp. | 2000-04-06 | Traditional | PDF ↗ |
| K000172 | DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS | DePuy Orthopaedics, Inc. | 2000-02-03 | Special | PDF ↗ |
| K982859 | UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM | Plus Orthopedics | 1999-07-30 | Traditional | PDF ↗ |
| K980665 | REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS | Biomet, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K974434 | OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS | Osteonics Corp. | 1998-01-12 | Traditional | PDF ↗ |
| K971938 | REPICCI II UNICONDYLAR KNEE | Biomet, Inc. | 1997-08-25 | Traditional | PDF ↗ |
| K954481 | P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM | Johnson & Johnson Professionals, Inc. | 1996-10-10 | Traditional | PDF ↗ |
| K961900 | TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM | Wrightmedicaltechnologyinc | 1996-07-25 | Traditional | PDF ↗ |
| K960617 | ADVANCE TIBIAL COMPONENT | Wrightmedicaltechnologyinc | 1996-05-08 | Traditional | PDF ↗ |
| K955778 | NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM | Intermedics Orthopedics | 1996-03-08 | Traditional | PDF ↗ |
| K944538 | GAS PLASMA STERILIZATION | Depuy, Inc. | 1995-09-26 | Traditional | PDF ↗ |
| K940389 | S.T.E.P. UNI-KNEE | S.T.E.P. Orthopaedics, Inc. | 1995-01-19 | Traditional | PDF ↗ |
| K933935 | CKS POROUS COATED FEMORAL COMPONENT | Techmedica, Inc. | 1994-10-11 | Traditional | PDF ↗ |
| K923011 | OSTEONICS UNIX UNICOMPARTMENTAL | Osteonics Corp. | 1993-11-30 | Traditional | PDF ↗ |
| K910968 | P.F.C. UNICONDYLAR KNEE SYSTEM | Johnson & Johnson Orthopaedics, Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K911373 | OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP | Osteonics Corp. | 1991-06-26 | Traditional | PDF ↗ |
| K902538 | WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION | Dow Corning Wright | 1990-07-06 | Traditional | PDF ↗ |
| K890044 | BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE | Biopro, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K883969 | UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM | Intermedics Orthopedics | 1989-04-19 | Traditional | PDF ↗ |
| K884837 | KINEMAX TIBIAL WEDGE | Howmedica Corp. | 1989-02-17 | Traditional | PDF ↗ |
| K882241 | KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM | Kirschner Medical Corp. | 1988-06-29 | Traditional | PDF ↗ |
| K873601 | AGC UNICOMPARTMENTAL KNEE PROSTHESIS | Biomet, Inc. | 1988-01-20 | Traditional | PDF ↗ |
| K864070 | WHITESIDE ORTHOLOC (TM) | Dow Corning Wright | 1987-01-27 | Traditional | PDF ↗ |
| K862125 | ARIZONA CONDYLAR TIBIAL PLATEAU | Depuy, Inc. | 1986-06-27 | Traditional | PDF ↗ |
| K860133 | MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU | Depuy, Inc. | 1986-03-10 | Traditional | PDF ↗ |
| K842367 | HOWMEDICA KINEMATIC II TIBIAL WEDGE | Howmedica Corp. | 1984-08-17 | Traditional | PDF ↗ |
| K834298 | UNICONDYLAR FIBER METAL KNEE | Zimmer, Inc. | 1984-02-13 | Traditional | PDF ↗ |
| K831143 | P.C.A. UNICOMPARTMENTAL KNEE PROSTHES | Howmedica Corp. | 1983-08-16 | Traditional | PDF ↗ |
| K821341 | IOI METAL BACKED TIBIAL COMPONENT | Intermedics Orthopedics | 1982-06-03 | Traditional | PDF ↗ |
| K820002 | BARD CONTOUR LINK S.K.I. KNEE SYS | C.R. Bard, Inc. | 1982-05-27 | Traditional | PDF ↗ |
| K820030 | HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE | Howmedica Corp. | 1982-02-05 | Traditional | PDF ↗ |
| K812012 | TOWNLEY UNICONDYLAR KNEE | Depuy, Inc. | 1981-09-24 | Traditional | PDF ↗ |
| K810540 | KNEE PROSTHESIS | Cintor Orthopaedic Div. | 1981-04-07 | Traditional | PDF ↗ |
| K810060 | P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH | Howmedica Corp. | 1981-04-07 | Traditional | PDF ↗ |
| K810616 | MILLER MULTI-RADIUS TOTAL KNEE | Zimmer, Inc. | 1981-03-20 | Traditional | PDF ↗ |
| K810230 | CONDYLAR KNEE W/METAL ENCAPSULATED TIB | Hexcel Medical | 1981-03-06 | Traditional | PDF ↗ |
| K802446 | RANAWAT ESF TOTAL CONDYLAR KNEE | Howmedica Corp. | 1980-10-31 | Traditional | PDF ↗ |
| K792619 | RMC KNEE METAL SHOE TIBIAL COMPONENTS | Richard'S Medical Equip., Inc. | 1980-02-05 | Traditional | PDF ↗ |
| K792325 | LIVERPOOL KNEE PROSTHESIS | Downs Surgical , Ltd. | 1980-01-21 | Traditional | PDF ↗ |
| K790762 | PLATFORM TCCK TOTAL KNEE | Biomet, Inc. | 1979-05-14 | Traditional | PDF ↗ |
| K790349 | TOTAL CONDYLAR KNEE PROSTHESIS | Howmedica Corp. | 1979-03-06 | Traditional | PDF ↗ |
| K790350 | POSTERIOR CRUCIATE CONDYLAR TIBIAL | Howmedica Corp. | 1979-03-06 | Traditional | PDF ↗ |
| K790348 | ANAMETRIC TIBIAL COMPONENT METAL TRAY | Howmedica Corp. | 1979-03-06 | Traditional | PDF ↗ |
| K781608 | CENTRAL PEG TIBIAL COMPONENT | Howmedica Corp. | 1978-09-27 | Traditional | PDF ↗ |
| K780299 | TOTAL KNEE SYSTEM | Richard'S Medical Equip., Inc. | 1978-04-27 | Traditional | PDF ↗ |
| K761278 | TOTAL TIBIAL KNEE | Depuy, Inc. | 1977-01-05 | Traditional | PDF ↗ |
| K760842 | GEOMEDIC ANAMETRIC TOTAL KNEE | Howmedica Corp. | 1976-10-20 | Traditional | PDF ↗ |
| K760744 | TAVERNETTI-TENNANT | Cutter Laboratories, Inc. | 1976-10-07 | Traditional | PDF ↗ |
| K760334 | PROSTEHSIS, TOTAL KNEE REPLACEMENT | Depuy, Inc. | 1976-08-11 | Traditional | PDF ↗ |
| K760245 | PROSTHESIS, RICHARDS MOD II KNEE | Richard'S Medical Equip., Inc. | 1976-07-26 | Traditional | PDF ↗ |
Product code HRY · Class II · Orthopedic. Data: openFDA.