# K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Sep 25, 2023 after 269 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: 5 generations back to K850886 (1985). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093978: Exactech Equinoxe Proximal Humerus Fracture Plate System, Exactech, Inc. (2010) Summary page 4.
- K153340: Epic Extremity Plate System, Epic Extremity, LLC (2016) Summary page 3.
- K111352: Talon Distalfix Proximal Femoral Nail, Orthopedic Designs North America, Inc. (2011) Summary page 4.
- K051412: Humeral Head Plate with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 4.
- K133668: Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate, Right, Aft Greater Tuberosity Cannul, Shoulder Options, Inc. (2014) Summary page 4.

## Indications for use
The Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus. The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.

Source page: https://510kreport.com/device/K223933
Methodology: https://510kreport.com/methodology