# K042321: Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jan 28, 2005 after 155 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: 5 generations back to K800494 (1980). 24 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 1.
- K032895: BI-Angular Shoulder System, Biomet, Inc. (2003) Summary page 1.
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System, Biomet, Inc. (2003) Summary page 1.
- K992899: Bio-Modular Shoulder Offset Humeral Heads, Biomet, Inc. (1999) 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 Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Heads are for use in primary and revision shoulder joint replacement procedures in cases of: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid arthritis * Revision where other devices or treatments have failed * Correction of functional deformity * Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods * Oncology applications

Source page: https://510kreport.com/device/K042321
Methodology: https://510kreport.com/methodology