OOG · Knee Arthroplasty Implantation System
Orthopedic · 21 CFR 888.3560 · Class 2
Overview
| Product Code | OOG |
|---|---|
| Device Name | Knee Arthroplasty Implantation System |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230850 | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. | Dec 20, 2023 | SESE |
| K203421 | Triathlon AS-1 | Conformis, Inc. | Apr 19, 2021 | SESE |
Top Applicants
- Conformis, Inc. — 1 clearance
- Enhatch, Inc. — 1 clearance
