# K060545: Unity Humeral Plate

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Apr 21, 2006 after 51 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041860 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 1.
- K041709: Numelock II System, Howmedica Osteonics Corp. (2004) Summary page 1.

## Indications for use
The Tormer humeral plate is indicated for simple or complex fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Source page: https://510kreport.com/device/K060545
Methodology: https://510kreport.com/methodology