# K012377: Oxford Modular Shoulder Prosthesis, 192.XXX Catalogue Series

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Mar 11, 2002 after 228 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992119 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 2.

## Indications for use
The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including: osteoarthritis rheumatoid arthritis revision cases where other devices or treatments have failed correction of functional deformity treatment of acute fracture of the humeral head unmanageable using other treatment methods cuff tear arthroplasty Hemi-resurfacing is also indicated for: humeral head fractures avascular necrosis of the femoral head

Source page: https://510kreport.com/device/K012377
Methodology: https://510kreport.com/methodology