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.
Cleared Devices (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
- Enhatch, Inc. — 1 clearance
- Conformis, Inc. — 1 clearance
