# K950594: Hemi-Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: May 22, 1995 after 102 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 1 cites it directly.
0 of 21 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
- K141990: Encore Humeral Shoulder Stem (2014), 19 descendants of its own
- K172351: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (2017), 18 descendants of its own
- K190290: AltiVate Reverse Humeral Stem, 48mm (2019), 15 descendants of its own
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (2021), 5 descendants of its own
- K211991: Catalyst R1 Reverse Shoulder System (2021), 3 descendants of its own

Source page: https://510kreport.com/device/K950594
Methodology: https://510kreport.com/methodology