# K171010: Latitude EV Total Elbow Arthroplasty

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Aug 31, 2017 after 149 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: 5 generations back to K883665 (1989). 11 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100562: Latitude Elbow Prosthesis, Tornier, Inc. (2010) Summary page 4.
- K053189: Coonrad/Morrey Total Elbow, Model 8105 Series, Zimmer, Inc. (2005) Summary page 4.

## Most influential descendants
- K181362: TEMA Elbow System (2019), 1 descendant of its own
- K182461: LATITUDE EV Total Elbow Arthroplasty (2018), 1 descendant of its own
- K222807: TEMA Elbow system - Line extension (2022), 0 descendants of its own
- K193247: LATITUDE EV™ Total Elbow Arthroplasty (2020), 0 descendants of its own

## Indications for use
The Latitude EV™ Total Elbow Arthroplasty system 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 osteoarthritis 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 Latitude EV™ Total Elbow Arthroplasty system is intended for cemented use only.

Source page: https://510kreport.com/device/K171010
Methodology: https://510kreport.com/methodology