FDA product code KYJ: Prosthesis, Finger, Constrained, Polymer
KYJ is the FDA product code for prosthesis, finger, constrained, polymer. It is a Class II device, regulated under 21 CFR 888.3230 and reviewed by the Orthopedic panel. FDA has cleared 14 510(k) submissions under KYJ, 3 in the last five years, from 11 different applicants. The average 510(k) review took 206 days (median 176). FDA has posted 4 recalls for KYJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Finger, Constrained, Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3230 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KYJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 449 |
| 2023 | 2 | 235 |
Compare with all 510(k) review times · Search every KYJ clearance
Top KYJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ascension Orthopedics, Inc. | 3 | 2023-12-14 |
| Depuy, Inc. | 2 | 2000-08-29 |
| Brm Extremities Srl | 1 | 2023-04-04 |
| Keri Medical SA | 1 | 2022-07-27 |
| Osteotec, Ltd. | 1 | 2015-04-17 |
6 more applicants have KYJ clearances. See the full list in Caduvo.
Most recent KYJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233670 | Ascension Orthopedics, Inc. | Ascension Silicone MCP; Ascension Silicone PIP | 2023-12-14 | 29 |
| K220142 | Brm Extremities Srl | BRM Digitalis Spacer | 2023-04-04 | 441 |
| K211385 | Keri Medical SA | KeriFlex® MCP and PIP Finger Joint Prostheses | 2022-07-27 | 449 |
| K140453 | Osteotec, Ltd. | OSTEOTEC SILICONE FINGER IMPLANT | 2015-04-17 | 417 |
| K083107 | DePuy Orthopaedics, Inc. | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | 2009-02-09 | 112 |
Recalls for KYJ devices
4 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-06-18.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KYJ?
KYJ is the FDA product code for prosthesis, finger, constrained, polymer. It is a Class II device, regulated under 21 CFR 888.3230 and reviewed by the Orthopedic panel.
What device class is KYJ?
Class II, regulation 21 CFR 888.3230. Typical premarket route: 510(k).
How long does a 510(k) take for product code KYJ?
Across 14 cleared submissions the average was 206 days from receipt to decision (median 176).
Which companies have the most KYJ clearances?
Ascension Orthopedics, Inc. (3); Depuy, Inc. (2); Brm Extremities Srl (1); Keri Medical SA (1); Osteotec, Ltd. (1).
Have KYJ devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2025-06-18.
Next steps
- Run an FDA pathway report with predicate devices for product code KYJ
- Run a recall and safety report across every KYJ manufacturer
- Watch product code KYJ 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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