# K000683: Modified Single Axle Total Elbow

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jun 27, 2000 after 119 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.
16 later devices descend from it; 1 cites it directly.
0 of 17 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
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System (2003), 15 descendants of its own
- K042321: Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head (2005), 9 descendants of its own
- K043505: Discovery-Mosaic Total Humerus System (2005), 8 descendants of its own
- K111746: Comprehensive Segmental Revision System (SRS) (2011), 7 descendants of its own
- K143659: Equinoxe Mega Prosthesis (2015), 5 descendants of its own

Source page: https://510kreport.com/device/K000683
Methodology: https://510kreport.com/methodology