# K193247: LATITUDE EV™ Total Elbow Arthroplasty

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Aug 5, 2020 after 254 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: 7 generations back to K883665 (1989). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182461: LATITUDE EV Total Elbow Arthroplasty, Tornier, Inc. (2018) Summary page 4.
- K171010: Latitude EV Total Elbow Arthroplasty, Tornier, Inc. (2017) Summary page 4.

## 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/K193247
Methodology: https://510kreport.com/methodology