MBV · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Orthopedic · 21 CFR 888.3560 · Class 2
Overview
| Product Code | MBV |
|---|---|
| Device Name | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010212 | OFFSET TIBIAL TRAY | Biomet, Inc. | Feb 14, 2001 | SESE |
| K884824 | TRICON-M TOTAL KNEE SYSTEM | Richards Medical Co., Inc. | Nov 21, 1989 | SN |
| K873429 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE | Protek, Inc. | Oct 28, 1987 | SESE |
| K853730 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP | Protek, Inc. | Feb 18, 1986 | SESE |
| K833200 | TRICON M TOTAL KNEE SYSTEM | Richards Medical Co., Inc. | Nov 29, 1983 | SESE |
| K831441 | POROCOAT FREEMAN/SAMUELSON TOTAL KNEE | Depuy, Inc. | Sep 1, 1983 | SESE |
| K832302 | MARK I TOTAL KNEE SYS. ARTHROPLASTY | Advanced Biosearch Assn. | Aug 16, 1983 | SESE |
| K830726 | MARK I & II TOTAL KNEE REPLACE. SYS | Advanced Biosearch Assn. | Jun 22, 1983 | SESE |
| K823837 | RMC TOTAL KNEE SYSTEM | Richard'S Medical Equip., Inc. | Mar 29, 1983 | SESE |
| K830408 | FREEMAN/SAMUELSON TOTAL KNEE | Depuy, Inc. | Feb 24, 1983 | SESE |
| K822583 | TOTAL KNEE SYSTEM | Richard'S Medical Equip., Inc. | Oct 4, 1982 | SESE |
| K802921 | ICLH TIBIAL PLATEAU | Depuy, Inc. | Jan 8, 1981 | SESE |
| K780904 | KNEE, TOTAL, FEMORAL & TIBIAL | Depuy, Inc. | Jun 22, 1978 | SESE |
| K780284 | TIBIAL PLATEU | Depuy, Inc. | Mar 15, 1978 | SESE |
Top Applicants
- Depuy, Inc. — 5 clearances
- Richards Medical Co., Inc. — 2 clearances
- Richard'S Medical Equip., Inc. — 2 clearances
- Protek, Inc. — 2 clearances
- Advanced Biosearch Assn. — 2 clearances
