US-based medical device technology firm Exactech has secured the US Food and Drug Administration (FDA) 510(k) clearance for its Equinoxe scapula reconstruction system.
Equinoxe system is intended for acromial and scapular spine fractures, which are associated with reverse total shoulder arthroplasty (rTSA) implants.
Acromial and scapular fractures, the rare and severe complications are infrequent, and pose a significant challenge in rTSA procedures, affecting up to 10.9% of patients.
Exactech’s new scapula reconstruction system aims to bridge the gap by providing a comprehensive solution for surgeons dealing with these complex fractures.
The system was developed by a team of medical professionals, including Paley Orthopedic and Spine Institute MD Jonathan Levy and Atlantis Orthopedics DO Howard Routman.
Exactech extremities SVP 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.
“I am proud that Exactech is the first to provide a system with design elements that help support surgeons in managing these complex cases.”
The Equinoxe scapula reconstruction system is the only trauma solution specifically designed for acromial and scapular fractures in the context of rTSA.
The system provides orthopaedic surgeons with multiple plating techniques, adaptable to various rTSA implant designs.
It features anatomically contoured plates available in multiple lengths, enabling precise management of fractures across diverse patient anatomies.
The plates are designed to accommodate the Levy Type 1, 2, 2A, and 2B fracture classification patterns.
They incorporate integral hooks to support the scapula against the deltoid’s pull and rTSA prosthesis loading.
In laboratory research use of a lateral hook plate has been shown to enhance fixation of the lateral acromion.
Exactech will launch a pilot of the Equinoxe system with limited availability in the US later this year.
Howard Routman said: “Finally, a plating system specifically designed for management of this challenging complication will be available in the US.
“The release of this implant will represent a new paradigm for open reduction internal fixation of acromial and scapular spine fractures.”
Jonathan Levy said: “I am proud of the plating system that we have developed – an implant system for acute treatment which will help bring much-needed attention to manage this often-devastating complication.”
