# K070963: Reunion HA Fracture Stem

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 4, 2007 after 29 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
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) Solar® ReUnionTM Fracture Stem: named in the summary without a submission number

## Recalls of this device
- Nov 13, 2008 · Not classified · Z-0901-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

## 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 fractures and/or dislocation. * Clinical management problems where arthodesis 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 fractures and/or dislocation. * Clinical management problems where arthodesis 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/K070963
Methodology: https://510kreport.com/methodology