# K972691: Abc Total Elbow Prothesis

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 15, 1997 after 90 days
- Product code: JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3160
- 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 K810847 (1981). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955099: Sorbie Total Elbow System, Wrightmedicaltechnologyinc (1996) Summary page 2.
- K861680: Osteonics Elbow Prosthesis, Osteonics Corp. (1986) Summary page 2.
- K883665: Coonrad Iii Total Elbow, Zimmer, Inc. (1989) Summary page 2.
- K810847: Pritchard Surface Replacement Elbow, Depuy, Inc. (1981) Summary page 2.
- K820957: Suface Replacement Elbow, Howmedica Corp. (1982) Summary page 2.
- (no number) Capitello Condylar: named in the summary without a submission number

## Most influential descendants
- K983036: Single Axle Total Elbow (1999), 0 descendants of its own

## Indications for use
The ABC Elbow Prothesis 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 device is a single use implant. It is intended for use with bone cement.

Source page: https://510kreport.com/device/K972691
Methodology: https://510kreport.com/methodology