# K122541: Orthofix Contours Proimal Humeral Plate (PHP)

- Pathway: 510(k) (Special)
- Applicant: Orthofix Srl
- Decided: Sep 20, 2012 after 30 days
- Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single 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 K062920 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062920: Orthofix Titanium Humeral Plating System LSP, Orthofix Srl (2006) Summary page 1.

## Indications for use
The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K122541
Methodology: https://510kreport.com/methodology