FDA Clears Exactech’s Scapula Reconstruction System

Exactech has received FDA 510(k) clearance for its Equinoxe scapula reconstruction system, designed to treat rare but serious acromial and scapular spine fractures linked to reverse total shoulder arthroplasty (rTSA). Currently, there is no standard solution for these complications.

The system enables orthopaedic surgeons to use single or dual plating, regardless of implant design, and includes anatomically contoured plates in various lengths. These plates are suited for managing Levy Type I, II, IIA, and IIB fractures and feature integrated hooks to support the scapula and counter deltoid and rTSA-induced forces.

Lab research shows the lateral hook plate enhances fixation of the lateral acromion. A limited pilot launch is planned in the US later in 2025.

The system was co-designed by surgeons Jonathan Levy, Peter Cole, Howard Routman, Michael McKee, George Athwal, and Joaquin Sanchez-Sotelo.

10-07-2025