# K955731: Osteonics Shoulder Humeral Components

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Mar 5, 1996 after 78 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.
242 later devices descend from it; 4 cite it directly.
1 of 243 devices in its family (counting itself) has 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) Osteonics® Shoulder Humeral Components: named in the summary without a submission number
- (no number) Global Shoulder: named in the summary without a submission number
- (no number) Bio-Modular Total Shoulder: named in the summary without a submission number
- (no number) Monospherical Shoulder Prosthesis: named in the summary without a submission number

## Most influential descendants
- K982981: New Zimmer Shoulder System (1998), 235 descendants of its own
- K041549: Zimmer Trabecular Metal Humeral Stem (2004), 218 descendants of its own
- K052906: Zimmer Trabecular Metal Reverse Shoulder System (2005), 216 descendants of its own
- K060704: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM (2006), 207 descendants of its own
- K063569: Equinoxe Reverse Shoulder System (2007), 190 descendants of its own

## Recalls of this device
- Nov 13, 2008 · Not classified · Z-0888-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

## Indications for use
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/K955731
Methodology: https://510kreport.com/methodology