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Ankle Arthroplasty Implantation System
FDA product code OYK · Class 2 · Orthopedic
33
Registered devices
11
Adverse events
2
Recalls
7
510(k) clearances
Devices with this code
Cadence Chamfer Cut Total Ankle System — 3D SYSTEMS, INC.Vantage 3D+ PSI — 3D SYSTEMS, INC.Vantage PSI — 3D SYSTEMS, INC.restor3d Kinos Axiom PSR — Restor3d, Inc.Vantage 3D+ PSI — 3D SYSTEMS, INC.Vantage 3D+ PSI — 3D SYSTEMS, INC.restor3d Kinos Axiom PSR — Restor3d, Inc.restor3d Kinos Axiom PSR — Restor3d, Inc.Cadence Flat Cut Total Ankle System — 3D SYSTEMS, INC.OPTIX — VILEX LLCSalto Talaris Flat Cut Total Ankle System — 3D SYSTEMS, INC.Salto Talaris Chamfer Cut Total Ankle System — 3D SYSTEMS, INC.Vantage 3D PSI — 3D SYSTEMS, INC.Salto Talaris Flat Cut Total Ankle System — 3D SYSTEMS, INC.Cadence Flat Cut Total Ankle System — 3D SYSTEMS, INC.Salto Talaris Chamfer Cut Total Ankle System — 3D SYSTEMS, INC.Cadence Chamfer Cut Total Ankle System — 3D SYSTEMS, INC.restor3d Kinos Axiom PSR — Restor3d, Inc.Cadence Chamfer Cut Total Ankle System — 3D SYSTEMS, INC.Salto Talaris Chamfer Cut Total Ankle System — 3D SYSTEMS, INC.Vantage PSI — 3D SYSTEMS, INC.restor3d Kinos Axiom PSR — Restor3d, Inc.restor3d Kinos Axiom PSR — Restor3d, Inc.Vantage PSI — 3D SYSTEMS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-27 | restor3d Inc. | Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrume |
| 2011-11-17 | Integra LifeSciences Corp. | During 6/30/2010 to 8/17/2011 the firm received five (5) incident complaints of breakage of the threaded part of the compression guide which potentially occurre |
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