# K243275: Equinoxe® Scapula Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jun 26, 2025 after 253 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: 4 generations back to K000684 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051083: Acumed Scapula Congruent Bone Plate System, Acumed, LLC (2005) Summary page 5.

## Indications for use
Equinoxe® Scapula Fracture System The Exactech@ Equinoxe® Scapula Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the scapula. Specific clinical indications for ORIF are as follows: Levy Type 1, IIA, and llB fractures, fracture dislocations, osteotomies, and non-unions of the acromion and scapular spine. The 3.5mm diameter and 2.7mm diameter Exactech@ EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech@ Equinoxe@ Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula. The Straight Plates of the EPIC Fracture Plate System (cleared under K172441) are also intended for use with the Exactech® Equinoxe@ Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula.

Source page: https://510kreport.com/device/K243275
Methodology: https://510kreport.com/methodology