# K983036: Single Axle Total Elbow

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 30, 1999 after 242 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: 2 generations back to K810847 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955916: Townley Total Elbow System, Biologically Oriented Prostheses (1996) Summary page 2.
- K980502: Osteonics Total Elbow System, Osteonics Corp. (1998) Summary page 2.
- K972691: Abc Total Elbow Prothesis, Biomet, Inc. (1997) Summary page 2.

## Indications for use
The Single Axle Total Elbow is indicated for use in theumatoid arthritis, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structure about the elbow. This device is a single use implant. It is intended for use with bone cement.

Source page: https://510kreport.com/device/K983036
Methodology: https://510kreport.com/methodology