LGE · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
Orthopedic · 21 CFR 888.3530 · Class 2
Overview
| Product Code | LGE |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing |
| Regulation | 21 CFR 888.3530 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992346 | KINEMATIC II ROTATING HINGE KNEE | Howmedica Osteonics Corp. | Aug 12, 1999 | SESE |
| K811630 | KINEMATIC ROTATING HINGE TOTAL KNEE PR. | Howmedica Corp. | Jul 1, 1981 | SESE |
Top Applicants
- Howmedica Osteonics Corp. — 1 clearance
- Howmedica Corp. — 1 clearance
