Equinoxe® Scapula Fracture System

The Exactech Equinoxe Scapula Fracture System is a set of metallic bone plates and screws designed for open reduction internal fixation (ORIF) of scapula fractures, including Levy Type I, IIA, and IIB fractures, fracture dislocations, osteotomies, and non-unions of the acromion and scapular spine. The system works with previously cleared EPIC screws and straight plates in various configurations.

The proposed device uses the same biocompatible materials and achieves fracture fixation through identical or similar mechanisms as the predicate. Both are provided non-sterile for single use and conform to recognized standards for multi-component bone screw and plate fixation systems. Differences exist only in geometry between the subject and predicate devices.

Cross-sectional and finite element analysis; clinically relevant cycled bend testing; ASTM F897 (corrosion assessment); ASTM F543 (screw testing); ISO 10993-1:2018 (biocompatibility).

Substantial equivalence is based on identical indications for use (with the addition of non-unions, a standard ORIF indication), same biocompatible materials, and equivalent fracture fixation mechanisms. Pre-clinical testing including bending fatigue, screw mechanical performance, corrosion, and biocompatibility assessment demonstrate that geometric differences do not alter intended use or performance requirements compared to the Acumed Scapula Congruent Bone Plate System predicate.