MBV
14 FDA 510(k) clearances · Product code
64 daysmedian time to decision
165 days90th percentile
14clearances measured
FDA profile
- Official device name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2011: 11 · 2012: 12 · 2013: 15 · 2015: 18 · 2017: 13 · 2019: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OFFSET TIBIAL TRAY (K010212) | Biomet, Inc. | 2001-02-14 |
| TRICON-M TOTAL KNEE SYSTEM (K884824) | Richards Medical Co., Inc. | 1989-11-21 |
| FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE (K873429) | Protek, Inc. | 1987-10-28 |
| FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP (K853730) | Protek, Inc. | 1986-02-18 |
| TRICON M TOTAL KNEE SYSTEM (K833200) | Richards Medical Co., Inc. | 1983-11-29 |
| POROCOAT FREEMAN/SAMUELSON TOTAL KNEE (K831441) | Depuy, Inc. | 1983-09-01 |
| MARK I TOTAL KNEE SYS. ARTHROPLASTY (K832302) | Advanced Biosearch Assn. | 1983-08-16 |
| MARK I & II TOTAL KNEE REPLACE. SYS (K830726) | Advanced Biosearch Assn. | 1983-06-22 |
| RMC TOTAL KNEE SYSTEM (K823837) | Richard'S Medical Equip., Inc. | 1983-03-29 |
| FREEMAN/SAMUELSON TOTAL KNEE (K830408) | Depuy, Inc. | 1983-02-24 |
| TOTAL KNEE SYSTEM (K822583) | Richard'S Medical Equip., Inc. | 1982-10-04 |
| ICLH TIBIAL PLATEAU (K802921) | Depuy, Inc. | 1981-01-08 |
| KNEE, TOTAL, FEMORAL & TIBIAL (K780904) | Depuy, Inc. | 1978-06-22 |
| TIBIAL PLATEU (K780284) | Depuy, Inc. | 1978-03-15 |
Track MBV automatically
Every clearance here is in the API, with alerts when new ones post.