# K000003: Tornier Total Elbow Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Oct 2, 2000 after 273 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.
9 later devices descend from it; 4 cite it directly.
0 of 10 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
- K050848: Tornier Elbow Prosthesis (2005), 7 descendants of its own
- K031218: Modification to Tornier Total Elbow Prosthesis (2003), 7 descendants of its own
- K070787: Latitude Elbow Prothesis (2007), 6 descendants of its own
- K100562: Latitude Elbow Prosthesis (2010), 5 descendants of its own
- K171010: Latitude EV Total Elbow Arthroplasty (2017), 4 descendants of its own

Source page: https://510kreport.com/device/K000003
Methodology: https://510kreport.com/methodology