# K925613: Proximal Humeral Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 14, 1994 after 708 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 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
- K020045: 3-Piece Proximal Humeral Replacement System (2002), 17 descendants of its own
- K022079: Short and Long Soft Tissue Attachment (2002), 16 descendants of its own
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System (2003), 15 descendants of its own
- K032895: BI-Angular Shoulder System (2003), 10 descendants of its own
- K042321: Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head (2005), 9 descendants of its own

Source page: https://510kreport.com/device/K925613
Methodology: https://510kreport.com/methodology