# K950521: Osteonics All  Polyethylene Glenoid Shoulder Component

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jun 16, 1995 after 130 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
No predicates in its family tree.
45 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K950521
Methodology: https://510kreport.com/methodology