Exactech has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Equinoxe scapular reconstruction system for acromial and scapular spine fractures.

Acromial and scapular fractures are a rare but devastating complication that can occur among every rTSA implant design. There’s currently no accepted treatment solution for patients with this challenging rTSA complication. Designed by Jonathan Levy, MD, Howard Routman, DO, Peter Cole, MD, George Athwal, MD, Michael McKee, MD, and Joaquin Sanchez-Sotelo, MD, Ph.D., the Equinoxe scapula reconstruction system is the only trauma solution designed to treat acromial and scapular fractures with rTSA in mind.

With the new device, surgeons can treat the fractures using single and dual plating, regardless of placement of any particular rTSA design. The system has a portfolio of anatomically contoured plates in multiple lengths to allow precise fracture management.

Different plate designs incorporate differentiated features to tailor treatment across the Levy Type I, II, IIA and IIB fracture classification patterns. Each contoured plate includes one or more integral hooks located anteriorly on the acromion, laterally on the acromion and/or a hook along the medial scapular border. This supports the scapula and counteracts the pull of the deltoid and biomechanical loading of the rTSA prosthesis.

“We organized a world-class design team to develop this comprehensive scapular plating system, bringing together surgeons with deep and diverse experience with rTSA implant designs from nearly every major manufacturer,” said Chris Roche, Exactech’s Sr. Vice President, Extremities. “This team collaborated to develop what we believe is the definitive treatment solution for acromial and scapular rTSA fracture patterns, an achievement that shows what’s possible when surgeons and industry work together to solve challenges. I am proud that Exactech is the first to provide a system with design elements that help support surgeons in managing these complex cases.”

In May, the company launched its next-generation Shoulder Planning App, a major update that introduces features to enhance surgical precision and streamline the planning process for shoulder replacement surgeries.