# K990598: Osteonics Solar Shoulder Humeral Bearing Head

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 15, 1999 after 19 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 K955731 (1996). 1 ancestor in all.
44 later devices descend from it; 1 cites it directly.
0 of 46 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 1.

## Most influential descendants
- K103835: Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) Reunion Tsa System N (2011), 43 descendants of its own
- K130759: Humelock II Cementless Shoulder System (2013), 31 descendants of its own
- K150488: Humelock II Reversible Shoulder System (2015), 30 descendants of its own
- K163669: Humeris Shoulder (2017), 20 descendants of its own
- K162455: Humelock Reversed Shoulder (2017), 17 descendants of its own

## Indications for use
The indications for the use of the Osteonics® Solar Shoulder Humeral Bearing Head , in keeping with those of other legally marketed Osteonics® shoulder components, are as follows: Indications 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. Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Source page: https://510kreport.com/device/K990598
Methodology: https://510kreport.com/methodology