FDA product code KYK: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
KYK is the FDA product code for prosthesis, knee, femorotibial, semi-constrained, cemented, metal/composite. It is a Class II device, regulated under 21 CFR 888.3500 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under KYK, from 2 different applicants. The average 510(k) review took 45 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite |
| Device class | Class II |
| Regulation | 21 CFR 888.3500 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KYK clearance
Top KYK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Depuy, Inc. | 2 | 1987-04-06 |
| Johnson & Johnson Professionals, Inc. | 1 | 1988-03-14 |
Most recent KYK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880826 | Johnson & Johnson Professionals, Inc. | MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM | 1988-03-14 | 13 |
| K871118 | Depuy, Inc. | MODIFIED TOWNLEY UNICONDYLAR KNEE | 1987-04-06 | 18 |
| K851341 | Depuy, Inc. | SYNATOMIC VARIABLE FIT TIBIAL PLATEAU | 1985-07-15 | 103 |
Recalls for KYK devices
openFDA lists no recalls for product code KYK.
Frequently asked questions
What is FDA product code KYK?
KYK is the FDA product code for prosthesis, knee, femorotibial, semi-constrained, cemented, metal/composite. It is a Class II device, regulated under 21 CFR 888.3500 and reviewed by the Orthopedic panel.
What device class is KYK?
Class II, regulation 21 CFR 888.3500. Typical premarket route: 510(k).
How long does a 510(k) take for product code KYK?
Across 3 cleared submissions the average was 45 days from receipt to decision (median 18).
Which companies have the most KYK clearances?
Depuy, Inc. (2); Johnson & Johnson Professionals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KYK
- Run a recall and safety report across every KYK manufacturer
- Watch product code KYK 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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