# K861680: Osteonics Elbow Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jun 27, 1986 after 57 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980428: Biomet Biaxial Total Elbow (1998), 1 descendant of its own
- K972691: Abc Total Elbow Prothesis (1997), 1 descendant of its own
- K983036: Single Axle Total Elbow (1999), 0 descendants of its own
- K982398: Biomet 100% Porous Coated Biaxial Total Elbow (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K861680
Methodology: https://510kreport.com/methodology