Panels › Orthopedic › Product code MBV · Class 2
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Regulation 888.3560
0510(k)s in 12 months (14 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MBV
| Company | 510(k)s | Recalls |
|---|---|---|
| Depuy, Inc. | 5 | 0 |
| Advanced Biosearch Assn. | 2 | 0 |
| Biomet, Inc. | 1 | 1 |
| Protek, Inc. | 2 | 0 |
| Richard'S Medical Equip., Inc. | 2 | 0 |
| Richards Medical Co., Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 14, 2001 | K010212 | OFFSET TIBIAL TRAY Biomet, Inc. | MBV |
| Nov 21, 1989 | K884824 | TRICON-M TOTAL KNEE SYSTEM Richards Medical Co., Inc. | MBV |
| Oct 28, 1987 | K873429 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE Protek, Inc. | MBV |
| Feb 18, 1986 | K853730 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP Protek, Inc. | MBV |
| Nov 29, 1983 | K833200 | TRICON M TOTAL KNEE SYSTEM Richards Medical Co., Inc. | MBV |
| Sep 1, 1983 | K831441 | POROCOAT FREEMAN/SAMUELSON TOTAL KNEE Depuy, Inc. | MBV |
| Aug 16, 1983 | K832302 | MARK I TOTAL KNEE SYS. ARTHROPLASTY Advanced Biosearch Assn. | MBV |
| Jun 22, 1983 | K830726 | MARK I & II TOTAL KNEE REPLACE. SYS Advanced Biosearch Assn. | MBV |
| Mar 29, 1983 | K823837 | RMC TOTAL KNEE SYSTEM Richard'S Medical Equip., Inc. | MBV |
| Feb 24, 1983 | K830408 | FREEMAN/SAMUELSON TOTAL KNEE Depuy, Inc. | MBV |
| Oct 4, 1982 | K822583 | TOTAL KNEE SYSTEM Richard'S Medical Equip., Inc. | MBV |
| Jan 8, 1981 | K802921 | ICLH TIBIAL PLATEAU Depuy, Inc. | MBV |
| Jun 22, 1978 | K780904 | KNEE, TOTAL, FEMORAL & TIBIAL Depuy, Inc. | MBV |
| Mar 15, 1978 | K780284 | TIBIAL PLATEU Depuy, Inc. | MBV |
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