# K103104: Special Orthopaedic Solutions Glenoid Shoulder Component

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 22, 2010 after 33 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- 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 K950521 (1995). 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)
- K950521: Osteonics All  Polyethylene Glenoid Shoulder Component, Osteonics Corp. (1995) Summary page 2.

## Indications for use
The indications for use of the total shoulder arthroplasty include: * Aseptic necrosis of the humneral head. * Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. * Proximal humeral fracture and/or dislocation. * Revision of previous unsuccessfuil total shoulder replacement, resurfacing or other procedure. * Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. The glenoid components are intended for cemented use only.

Source page: https://510kreport.com/device/K103104
Methodology: https://510kreport.com/methodology