# K020045: 3-Piece Proximal Humeral Replacement System

- Pathway: 510(k) (Special)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Jan 30, 2002 after 23 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
Longest line of descent: 1 generation back to K925613 (1994). 1 ancestor in all.
17 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925613: Proximal Humeral Replacement System, Biomet, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K042321: Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head (2005), 9 descendants of its own
- K043505: Discovery-Mosaic Total Humerus System (2005), 8 descendants of its own
- K111746: Comprehensive Segmental Revision System (SRS) (2011), 7 descendants of its own

## Indications for use
The indications for use for the 3-Piece Proximal Humeral Replacement System include noninflamatory degenerative joint disease including osteoarthritis and avascular Necrosis, rheumatoid arthritis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, treatment of acute fractures with humeral head involvement which are unmanageable using other treatment methods and oncology applications. This device is for use with bone cement.

Source page: https://510kreport.com/device/K020045
Methodology: https://510kreport.com/methodology