The US Food and Drug Administration (FDA) has granted 510(k) clearance for Exactech’s Equinoxe scapula reconstruction system for treating acromial and scapular spine fractures.
These fractures are uncommon but are a potentially severe complication that can arise with any design of reverse total shoulder arthroplasty (rTSA) implants.
According to the company, there is currently no established treatment option for patients facing this complication associated with rTSA.
To address this clinical gap, Exactech has created a solution designed to assist surgeons in addressing this specific challenge.
Orthopaedic surgeons can utilise the system to employ techniques such as single and dual plating, irrespective of any rTSA implant design placement.
This system offers a portfolio of anatomically contoured plates in various lengths, facilitating the fracture management tailored to individual patient anatomy.
The system's plates are designed to manage fractures classified under the Levy Type I, II, IIA, and IIB patterns.
Exactech noted that each plate features integral hooks that support the scapula and counteract the forces exerted by the deltoid and the biomechanical loading of the rTSA prosthesis.
Laboratory research has indicated that the lateral hook plate usage can improve the fixation of the lateral acromion.
The system is set for a pilot launch with limited availability in the US later this year.
It was designed by Jonathan Levy, Peter Cole, Howard Routman, Michael McKee, George Athwal, and Joaquin Sanchez-Sotelo.
Exactech Extremities' senior vice-president Chris Roche said: “We organised 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.
“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.”
In March 2025, the US Patent and Trademark Office (USPTO) issued patent 12,239,384 for the company’s Newton soft tissue balancing technology.
