# K051975: Porous Coated Discovery Elbow

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Sep 6, 2005 after 47 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003253 (2001). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 14 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)

## 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
- K090473: Discovery Elbow - X-Small (2009), 2 descendants of its own

## Recalls of this device
- Dec 14, 2011 · Not classified · Z-1071-2012: A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.
- Apr 29, 2011 · Not classified · Z-2660-2011: The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.

## Indications for use
The Porous Coated DiscoveryTM Elbow is intended for cemented use in patients with the following conditions: 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 severe functional deformity. 5. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatments.

Source page: https://510kreport.com/device/K051975
Methodology: https://510kreport.com/methodology