Product code MBV
- Device name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3560
- 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 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010212 | OFFSET TIBIAL TRAY | Biomet, Inc. | 2001-02-14 |
| K884824 | TRICON-M TOTAL KNEE SYSTEM | Richards Medical Co., Inc. | 1989-11-21 |
| K873429 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE | Protek, Inc. | 1987-10-28 |
| K853730 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP | Protek, Inc. | 1986-02-18 |
| K833200 | TRICON M TOTAL KNEE SYSTEM | Richards Medical Co., Inc. | 1983-11-29 |
| K831441 | POROCOAT FREEMAN/SAMUELSON TOTAL KNEE | Depuy, Inc. | 1983-09-01 |
| K832302 | MARK I TOTAL KNEE SYS. ARTHROPLASTY | Advanced Biosearch Assn. | 1983-08-16 |
| K830726 | MARK I & II TOTAL KNEE REPLACE. SYS | Advanced Biosearch Assn. | 1983-06-22 |
| K823837 | RMC TOTAL KNEE SYSTEM | Richard'S Medical Equip., Inc. | 1983-03-29 |
| K830408 | FREEMAN/SAMUELSON TOTAL KNEE | Depuy, Inc. | 1983-02-24 |
| K822583 | TOTAL KNEE SYSTEM | Richard'S Medical Equip., Inc. | 1982-10-04 |
| K802921 | ICLH TIBIAL PLATEAU | Depuy, Inc. | 1981-01-08 |
| K780904 | KNEE, TOTAL, FEMORAL & TIBIAL | Depuy, Inc. | 1978-06-22 |
| K780284 | TIBIAL PLATEU | Depuy, Inc. | 1978-03-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00880304000438 | BIOMET KNEE | Biomet Orthopedics, LLC | 2016-09-22 |
| 00880304000971 | Biomet® Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001725 | Maxim Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001718 | Maxim Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001688 | Maxim Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001466 | BIOMET KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001459 | Maxim Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001428 | Biomet® Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001398 | MAXIM® KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001374 | MAXIM KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001350 | Biomet® Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001343 | Biomet® Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001312 | Biomet® Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001305 | Biomet® Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001299 | Biomet® Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001022 | MAXIM KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 08428898831209 | BIOMET KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000964 | Biomet Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000957 | MAXIM KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000919 | Ascent Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000889 | Ascent Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000872 | Ascent Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000834 | BIOMET KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000766 | BIOMET KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000643 | MAXIM KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000087 | BIOMET KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000070 | Biomet Knee System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000056 | BIOMET KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304000025 | BIOMET KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 08428898831230 | BIOMET KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |