# K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 19, 2003 after 70 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925613 (1994). 7 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013042: Discovery Elbow, Biomet Orthopedics, Inc. (2001) Summary page 1.
- K000683: Modified Single Axle Total Elbow, Biomet, Inc. (2000) Summary page 1.
- K020045: 3-Piece Proximal Humeral Replacement System, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K022079: Short and Long Soft Tissue Attachment, Biomet, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K143659: Equinoxe Mega Prosthesis (2015), 5 descendants of its own
- K112905: Compress (R) Segmental Humeral Replacement System (2012), 5 descendants of its own

## Recalls of this device
- Feb 28, 2019 · Class II · Z-1081-2019: Lack of an adequate sterilization validation

## Indications for use
The indications for use for the Discovery TM Elbow - Mosaic TM Distal Humeral Replacement System include: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. Rheumatoid arthritis 3. Revision procedures where other treatments or devices have failed 4. Correction of functional deformity 5. Treatment of acute and chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods 6. Oncology applications This device is intended to be used with bone cement.

Source page: https://510kreport.com/device/K033280
Methodology: https://510kreport.com/methodology