# K050848: Tornier Elbow Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Jul 14, 2005 after 101 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) Summary page 1.
- K000003: Tornier Total Elbow Prosthesis, Tornier (2000) Summary page 1.
- K011567: Tornier Total Elbow Prosthesis, Tornier (2001)

## Cited in the summary but kept off the family tree
- K0331218: Tornier Elbow Prosthesis, Tornier. Number could not be read Summary page 1.

## 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 Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthtitis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques. The Tornier Elbow Prosthesis is intended for cemented use only.

Source page: https://510kreport.com/device/K050848
Methodology: https://510kreport.com/methodology