OYK
7 FDA 510(k) clearances · Product code
112 daysmedian time to decision
335 days90th percentile
7clearances measured
FDA profile
- Official device name
- Ankle Arthroplasty Implantation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3110
- Medical specialty
- Orthopedic
- FDA definition
- Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Salto Talaris Ankle PSI System (K243173) | 3D Systems, Inc. | 2024-10-25 |
| Cadence Ankle PSI System (K243174) | 3D Systems, Inc. | 2024-10-25 |
| Salto Talaris Ankle PSI System (K241148) | 3D Systems, Inc. | 2024-08-30 |
| Cadence Ankle PSI System (K241326) | 3D Systems, Inc. | 2024-08-30 |
| Vantage PSI System (K231585) | 3D Systems, Inc. | 2023-06-30 |
| Axiom PSR System (K223326) | Restor3D | 2023-03-30 |
| Vantage PSI System (K193432) | 3D Systems | 2020-11-09 |
Track OYK automatically
Every clearance here is in the API, with alerts when new ones post.