# K110320: Comprehensiveproximal Humeral Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jul 21, 2011 after 168 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 2 generations back to K000684 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062494: Ebi Optilock Upper Extremity Plating System, Ebi, L.P. (2006) Summary page 1.
- K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 1.

## Indications for use
The Comprehensive Proximal Humeral Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal humerus.

Source page: https://510kreport.com/device/K110320
Methodology: https://510kreport.com/methodology