FDA product code OYK: Ankle Arthroplasty Implantation System
OYK is the FDA product code for ankle arthroplasty implantation system. It is a Class II device, regulated under 21 CFR 888.3110 and reviewed by the Orthopedic panel. FDA has cleared 7 510(k) submissions under OYK, 6 in the last five years, from 3 different applicants. The average 510(k) review took 115 days (median 112); 72 days on average over the last three years. FDA has posted 2 recalls for OYK devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ankle Arthroplasty Implantation System |
| Device class | Class II |
| Regulation | 21 CFR 888.3110 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for OYK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 335 |
| 2023 | 2 | 90 |
| 2024 | 4 | 72 |
Compare with all 510(k) review times · Search every OYK clearance
Top OYK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3D Systems, Inc. | 5 | 2024-10-25 |
| Restor3D | 1 | 2023-03-30 |
| 3D Systems | 1 | 2020-11-09 |
Most recent OYK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243174 | 3D Systems, Inc. | Cadence Ankle PSI System | 2024-10-25 | 25 |
| K243173 | 3D Systems, Inc. | Salto Talaris Ankle PSI System | 2024-10-25 | 25 |
| K241326 | 3D Systems, Inc. | Cadence Ankle PSI System | 2024-08-30 | 112 |
| K241148 | 3D Systems, Inc. | Salto Talaris Ankle PSI System | 2024-08-30 | 127 |
| K231585 | 3D Systems, Inc. | Vantage PSI System | 2023-06-30 | 30 |
Recalls for OYK devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-27.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code OYK?
OYK is the FDA product code for ankle arthroplasty implantation system. It is a Class II device, regulated under 21 CFR 888.3110 and reviewed by the Orthopedic panel.
What device class is OYK?
Class II, regulation 21 CFR 888.3110. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYK?
Across 7 cleared submissions the average was 115 days from receipt to decision (median 112).
Which companies have the most OYK clearances?
3D Systems, Inc. (5); Restor3D (1); 3D Systems (1).
Have OYK devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2026-07-27.
Next steps
- Run an FDA pathway report with predicate devices for product code OYK
- Run a recall and safety report across every OYK manufacturer
- Watch product code OYK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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