OYK · Ankle Arthroplasty Implantation System
Orthopedic · 21 CFR 888.3110 · Class 2
Overview
| Product Code | OYK |
|---|---|
| Device Name | Ankle Arthroplasty Implantation System |
| Regulation | 21 CFR 888.3110 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Identification
An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing 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.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243174 | Cadence Ankle PSI System | 3D Systems, Inc. | Oct 25, 2024 | SESE |
| K243173 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | Oct 25, 2024 | SESE |
| K241326 | Cadence Ankle PSI System | 3D Systems, Inc. | Aug 30, 2024 | SESE |
| K241148 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | Aug 30, 2024 | SESE |
| K231585 | Vantage PSI System | 3D Systems, Inc. | Jun 30, 2023 | SESE |
| K223326 | Axiom PSR System | Restor3D | Mar 30, 2023 | SESE |
| K193432 | Vantage PSI System | 3D Systems | Nov 9, 2020 | SESE |
Top Applicants
- 3D Systems, Inc. — 5 clearances
- Restor3D — 1 clearance
- 3D Systems — 1 clearance
