# K011567: Tornier Total Elbow Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Tornier
- Decided: Jun 19, 2001 after 29 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
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. The FDA summary names no predicate by number.

## 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

## Indications for use
The Torier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases : to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformitics; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniqucs. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K011567
Methodology: https://510kreport.com/methodology