# K093978: Exactech Equinoxe Proximal Humerus Fracture Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: May 11, 2010 after 138 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: 3 generations back to K042059 (2004). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 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.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 1.
- K042059: Shoulder Fixation System, Hand Innovations, Inc. (2004) Summary page 1.
- K051728: Modification to Shoulder Fixation System, Hand Innovations, LLC (2005) Summary page 1.
- K060290: Shoulder Fixation System, Hand Innovations, LLC (2006) Summary page 1.

## Most influential descendants
- K120108: Aptus Proximal Humerus System (2012), 2 descendants of its own
- K181425: APTUS® Proximal Humerus System (2018), 1 descendant of its own
- K253916: APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (2026), 0 descendants of its own
- K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (2023), 0 descendants of its own

## Indications for use
The Equinoxe® Shoulder Proximal Humerus Fracture Plate System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Clinical indications are as follows: Fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Source page: https://510kreport.com/device/K093978
Methodology: https://510kreport.com/methodology