FDA product code KMC: Prosthesis, Hip, Semi-Constrained, Composite/Metal
KMC is the FDA product code for prosthesis, hip, semi-constrained, composite/metal. It is a Class II device, regulated under 21 CFR 888.3340 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under KMC, from 3 different applicants. The average 510(k) review took 103 days (median 92). FDA has posted 1 recall for KMC devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Composite/Metal |
| Device class | Class II |
| Regulation | 21 CFR 888.3340 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KMC clearance
Top KMC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zimmer, Inc. | 1 | 1994-04-26 |
| Intermedics Orthopedics | 1 | 1985-11-22 |
| Biomet, Inc. | 1 | 1985-11-01 |
Most recent KMC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K936044 | Zimmer, Inc. | ENHANCED MODULAR AUSTIN MOORE HIP | 1994-04-26 | 127 |
| K853524 | Intermedics Orthopedics | APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT | 1985-11-22 | 92 |
| K853259 | Biomet, Inc. | MALLORY/HEAD TOTAL HIP SYSTEM | 1985-11-01 | 91 |
Recalls for KMC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-10-11.
Frequently asked questions
What is FDA product code KMC?
KMC is the FDA product code for prosthesis, hip, semi-constrained, composite/metal. It is a Class II device, regulated under 21 CFR 888.3340 and reviewed by the Orthopedic panel.
What device class is KMC?
Class II, regulation 21 CFR 888.3340. Typical premarket route: 510(k).
How long does a 510(k) take for product code KMC?
Across 3 cleared submissions the average was 103 days from receipt to decision (median 92).
Which companies have the most KMC clearances?
Zimmer, Inc. (1); Intermedics Orthopedics (1); Biomet, Inc. (1).
Have KMC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-10-11.
Next steps
- Run an FDA pathway report with predicate devices for product code KMC
- Run a recall and safety report across every KMC manufacturer
- Watch product code KMC 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times