# K090473: Discovery Elbow - X-Small

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 25, 2009 after 29 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003253 (2001). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 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.
- K051975: Porous Coated Discovery Elbow, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K181362: TEMA Elbow System (2019), 1 descendant of its own
- K222807: TEMA Elbow system - Line extension (2022), 0 descendants of its own

## Indications for use
The Discovery Elbow - X-Small 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 functional deformity, 5. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods

Source page: https://510kreport.com/device/K090473
Methodology: https://510kreport.com/methodology