# K061677: Solar Purefix HA Shoulder

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 10, 2006 after 25 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955731 (1996). 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)
- K955731: Osteonics Shoulder Humeral Components, Osteonics Corp. (1996) Summary page 2.

## Recalls of this device
- Nov 15, 2007 · Not classified · Z-1236-2008: Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.

## Indications for use
For use as a Bipolar Shoulder Replacement: * Aseptic necrosis of the humeral head. * Painful, disabling joint disease of the shoulder resulting from: Degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. * Proximal humeral fracture and/or dislocation. * Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. · Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid. For use as a Total Shoulder Replacement: * Aseptic necrosis of the humeral head. * Painful, disabling joint disease of the shoulder resulting from: Degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. * Proximal humeral fracture and/or dislocation. * Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. * Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

Source page: https://510kreport.com/device/K061677
Methodology: https://510kreport.com/methodology