# K990712: Osteonics Solar Shoulder Bipolar System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 20, 1999 after 138 days
- Product code: MJT (Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Biomet Bi-Angular Bi-Polar Shoulder System: named in the summary without a submission number

## Indications for use
The subject components of the Osteonics® Solar™ Shoulder Bipolar System are single-use devices which are sold sterile and are intended for use with only the other components of the commercially available Osteonics® Solar™ Shoulder System. The indications for the use of the Osteonics® Solar™ Shoulder Bipolar System components, in keeping with those of other legally devices are as follows: Indications: * Aseptic necrosis of the humeral head . Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, theumatoid arthritis or post-traumatic arthritis. . Proximal humeral fracture and/ot dislocation L Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. ] Pathological conditions or age considerations which indicate 2 more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.

Source page: https://510kreport.com/device/K990712
Methodology: https://510kreport.com/methodology