# K980428: Biomet Biaxial Total Elbow

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 5, 1998 after 90 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: 1 generation back to K861680 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883665: Coonrad Iii Total Elbow, Zimmer, Inc. (1989) Summary page 2.
- K861680: Osteonics Elbow Prosthesis, Osteonics Corp. (1986) Summary page 2.

## Most influential descendants
- K982398: Biomet 100% Porous Coated Biaxial Total Elbow (1998), 0 descendants of its own

## Indications for use
The Biaxial Hinge Total Elbow is indicated for use in Rheumatoid 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 1linked 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/K980428
Methodology: https://510kreport.com/methodology