FDA product code KYM: Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
KYM is the FDA product code for metallic cemented glenoid hemi-shoulder prosthesis. It is a Class III device, regulated under 21 CFR 888.3680 and reviewed by the Orthopedic panel. Devices under KYM reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for pmas to be filed by 12/26/96 per 61 fr 50711 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Metallic Cemented Glenoid Hemi-Shoulder Prosthesis |
| Device class | Class III |
| Regulation | 21 CFR 888.3680 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for KYM devices
openFDA lists no recalls for product code KYM.
Frequently asked questions
What is FDA product code KYM?
KYM is the FDA product code for metallic cemented glenoid hemi-shoulder prosthesis. It is a Class III device, regulated under 21 CFR 888.3680 and reviewed by the Orthopedic panel.
What device class is KYM?
Class III, regulation 21 CFR 888.3680. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KYM
- Run a recall and safety report across every KYM manufacturer
- Watch product code KYM 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.