Product code HRY
- Device name
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3530
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P840049S001 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. | 1991-09-10 |
| P840049 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. | 1988-09-30 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193549 | SIGMA High Performance (HP) Partial Knee System | Depuy Ireland UC | 2020-04-16 |
| K190633 | NanoOrtho NanoKnee® System | Nanoortho, LLC | 2019-12-20 |
| K152631 | MPO Total Knee Systems MR Labeling | Microport Orthopedics, Inc. | 2016-03-23 |
| K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corporation | 2015-03-20 |
| K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | Biomet UK, Ltd. | 2014-03-28 |
| K131167 | UNIVATION | Aesculap Implant Systems, LLC | 2013-10-17 |
| K122277 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM | Biomet Manufacturing Corp | 2012-10-22 |
| K110415 | SIGNATURE PLANNER / SIGNATURE GUIDES | Materialise NV | 2011-05-16 |
| K100973 | EVOLUTION UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | 2010-08-10 |
| K082567 | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION | Howmedica Osteonics Corp. | 2008-10-03 |
| K081293 | UNIVATION UNICONDYLAR KNEE SYSTEM | Aesculap Implant Systems, Inc. | 2008-09-22 |
| K072704 | UNICOMPARTMENTAL KNEE | Valpo Orthopedic Technology, Inc. | 2008-02-19 |
| K071881 | TRIATHLON PKR SYSTEM | Howmedica Osteonics Corp. | 2007-10-09 |
| K070267 | DEPUY GCK TIBIAL COMPONENTS | DePuy Orthopaedics, Inc. | 2007-08-17 |
| K063515 | TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE | Biomet Manufacturing, Inc. | 2007-02-02 |
| K061681 | REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT | Biomet Manufacturing Corp | 2006-10-19 |
| K060412 | ACTIVE UNICOMPARTMENTAL KNEE SYSTEM | Australian Surgical Design & Manufacture | 2006-05-17 |
| K053299 | REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT | Biomet Manufacturing, Inc. | 2006-01-05 |
| K051721 | GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM | Global Orthopaedic Technology, USA, Inc. | 2005-10-26 |
| K050764 | UNIGLIDE UNICONDYLAR KNEE PROSTHESIS | Corin USA | 2005-08-24 |
| K042093 | VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS | Biomet, Inc. | 2004-11-01 |
| K040889 | EXACTECH OPTETRAK UNICONDYLAR KNEE | Exactech, Inc. | 2004-10-01 |
| K040268 | DEPUY PRESERVATION UNICONDYLAR TIBIA | DePuy Orthopaedics, Inc. | 2004-05-05 |
| K033351 | GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE | Global Orthopaedic Technology, USA, Inc. | 2004-03-11 |
| K033810 | NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM | Centerpulse Orthopedics, Inc. | 2004-03-05 |
| K032052 | UC-PLUS SOLUTION UNICONDYLAR KNEE | Plus Orthopedics | 2003-07-25 |
| K030446 | REPICCI LOCKED KEEL TIBIAL BEARING | Biomet, Inc. | 2003-03-06 |
| K030193 | ADVANCE LESS CONFORMING TIBIAL COMPONENT | Wrightmedicaltechnologyinc | 2003-02-20 |
| K022437 | UNI KNEE | Encore Medical L.P. | 2002-08-23 |
| K021621 | FIXED BEARING UNI COMPONENT | Biomet, Inc. | 2002-06-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613154557431 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327015621 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015843 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015836 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015829 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015805 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015782 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015768 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015751 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015744 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015737 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015713 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015690 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015669 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015645 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015638 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015614 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015584 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015577 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015560 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015553 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015539 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015508 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015492 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014600 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014594 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014587 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014570 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014556 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014549 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |