# K043505: Discovery-Mosaic Total Humerus System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 9, 2005 after 51 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: 4 generations back to K925613 (1994). 8 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System, Biomet, Inc. (2003) Summary page 1.
- K020045: 3-Piece Proximal Humeral Replacement System, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K111746: Comprehensive Segmental Revision System (SRS) (2011), 7 descendants of its own
- K143659: Equinoxe Mega Prosthesis (2015), 5 descendants of its own
- K153398: Comprehensive SRS/Nexel Elbow (2016), 3 descendants of its own
- K173411: Comprehensive Segmental Revision System (SRS) (2018), 2 descendants of its own
- K223631: Comprehensive Segmental Revision System (SRS) (2023), 1 descendant of its own

## Indications for use
The indications for use for the Discovery - Mosaic Total Humerus System include: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2. Rheumatoid arthritis 3. Revision where other devices or treatments have failed 4. Correction of functional deformity 5. Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods 6. Oncology applications The Discovery - Mosaic Total Humerus System is intended for cemented use only.

Source page: https://510kreport.com/device/K043505
Methodology: https://510kreport.com/methodology