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.
Recent Cleared Devices (14 of 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
- Advanced Biosearch Assn. — 2 clearances
- Protek, Inc. — 2 clearances
- Richard'S Medical Equip., Inc. — 2 clearances
- Richards Medical Co., Inc. — 2 clearances
