# K031218: Modification to Tornier Total Elbow Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Tornier
- Decided: May 16, 2003 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
Longest line of descent: 2 generations back to K883665 (1989). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973357: Coonrad/Morrey Total Elbow, New Hinge Pin, Zimmer, Inc. (1998) Summary page 1.
- K955099: Sorbie Total Elbow System, Wrightmedicaltechnologyinc (1996)
- K000003: Tornier Total Elbow Prosthesis, Tornier (2000)
- K011567: Tornier Total Elbow Prosthesis, Tornier (2001)

## Most influential descendants
- 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
- K181362: TEMA Elbow System (2019), 1 descendant of its own
- K182461: LATITUDE EV Total Elbow Arthroplasty (2018), 1 descendant of its own

## Indications for use
The Tornier 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 deformities; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniques. The Tornier Total Elbow Prosthesis is intended for cemented use only.

Source page: https://510kreport.com/device/K031218
Methodology: https://510kreport.com/methodology