# K100562: Latitude Elbow Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Jun 29, 2010 after 120 days
- Product code: JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3160
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K883665 (1989). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000003: Tornier Total Elbow Prosthesis, Tornier (2000) Summary page 1.
- K011567: Tornier Total Elbow Prosthesis, Tornier (2001)
- K031218: Modification to Tornier Total Elbow Prosthesis, Tornier (2003) Summary page 1.
- K050848: Tornier Elbow Prosthesis, Tornier (2005) Summary page 1.
- K070787: Latitude Elbow Prothesis, Tornier (2007) Summary page 1.

## Most influential descendants
- 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
- K222807: TEMA Elbow system - Line extension (2022), 0 descendants of its own
- K193247: LATITUDE EV™ Total Elbow Arthroplasty (2020), 0 descendants of its own

## Recalls of this device
- Mar 3, 2025 · Class II · Z-1651-2025: A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actua
- Jun 23, 2011 · Not classified · Z-3082-2011: Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed.

## Indications for use
The Tornier Inc. Latitude 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 Inc. Latitude Elbow Prosthesis is intended for cemented use only.

Source page: https://510kreport.com/device/K100562
Methodology: https://510kreport.com/methodology