# K112663: Enhatch Orthopaedics Patient/Technique-Specific Humeral

- Pathway: 510(k) (Traditional)
- Applicant: Enhatch Orthopaedics, LLC
- Decided: Mar 12, 2012 after 181 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: 1 generation back to K000684 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 1.
- K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 2.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 2.

## Indications for use
The EnHatch Orthopaedics Patient Optimized Humeral Fracture System is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal Humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K112663
Methodology: https://510kreport.com/methodology