# K013042: Discovery Elbow

- Pathway: 510(k) (Special)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Oct 10, 2001 after 30 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003253 (2001). 1 ancestor in all.
23 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003253: Biomet's Minimally Constrained Elbow, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System (2003), 15 descendants of its own
- K051975: Porous Coated Discovery Elbow (2005), 11 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

## Recalls of this device
- May 15, 2014 · Class II · Z-1925-2014: Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgica
- May 23, 2008 · Not classified · Z-0032-2009: The component in the package is not the correct size.
- May 23, 2008 · Not classified · Z-0033-2009: The component in the package is not the correct size.

## Indications for use
The Discovery Elbow is indicated for use with the following conditions: Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis Rheumatoid arthritis Revisions where other treatments or devices have failed Correction of severe functional deformity Treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods This device is intended to be used with bone cement.

Source page: https://510kreport.com/device/K013042
Methodology: https://510kreport.com/methodology