# K062113: Solar Reunion Fracture Stem

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 3, 2006 after 71 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- 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.
44 later devices descend from it; 2 cite it directly.
0 of 45 devices 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® Shoulder Humeral Components: named in the summary without a submission number
- (no number) Solar® PureFix® HA Shoulder: named in the summary without a submission number
- (no number) Tornier Aequalis Shoulder Fracture System: named in the summary without a submission number

## 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

## Recalls of this device
- May 9, 2007 · Not classified · Z-0080-2008: The plasma spray may delaminate from the proximal portion of the humeral stem.

## 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/K062113
Methodology: https://510kreport.com/methodology