Exactech Announces FDA Clearance of First-to-Market Scapula Reconstruction System for Acromial Stress Fractures

GAINESVILLE, Fla., July 9, 2025 /PRNewswire/ -- Exactech, a global medical technology leader, announced the Equinoxe® Scapula Reconstruction System for acromial and scapular spine fractures has received 510(k) clearance¹ from the U.S. Food and Drug Administration, marking a significant advancement in the treatment of acromial and scapular spine fractures.

Acromial and scapular fractures are a rare but devastating complication that can occur among every rTSA implant design. The reported rate of acromial and scapular fractures after rTSA averages 2.8 percent but can be as high as 10.9 percent for some patient diagnoses.² There is currently no accepted treatment solution for patients with this challenging rTSA complication. Recognizing this unmet clinical need, Exactech developed a novel solution to help surgeons treat this unique complication.

Designed by Jonathan Levy, MD, Howard Routman, DO, Peter Cole, MD, George Athwal, MD, Michael McKee, MD, and Joaquin Sanchez-Sotelo, MD, PhD, the Equinoxe Scapula Reconstruction System is the only trauma solution designed to treat acromial and scapular fractures with rTSA in mind.

"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." 

The Equinoxe Scapula Reconstruction System allows orthopedic surgeons to treat scapular fractures using several different techniques, including single and dual plating, regardless of placement of any particular rTSA implant design. This novel system features a versatile portfolio of anatomically contoured plates provided in multiple lengths to enable precise fracture management across the range of patient anatomy with the goal of restoring function.

"Finally, a plating system specifically designed for management of this challenging complication will be available in the United States," said Howard Routman, DO (Atlantis Orthopedics). "This dual plating system is impactful because it was designed to not only respect the variable scapular anatomy and variable fracture patterns, but also because it respects the unique biomechanics of the rTSA, which stresses the scapular bone uniquely. The release of this implant will represent a new paradigm for open reduction internal fixation of acromial and scapular spine fractures."

The Equinoxe Scapula Reconstruction System includes a range of different plate designs incorporating many differentiated features to tailor treatment across the Levy^3-4 Type I, II, IIA and IIB fracture classification patterns. Most significantly, 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) to support the scapula and counteract the pull of the deltoid and the biomechanical loading of the rTSA prosthesis. Previous laboratory research has suggested that the use of a lateral hook plate improved fixation of the lateral acromion.⁵

"I've spent the better part of my career trying to figure out how and why acromial fractures occur after reverse shoulder replacement," said Jonathan Levy, MD, Paley Orthopedic and Spine Institute. "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."

Current American Shoulder and Elbow Surgeons President Joaquin Sanchez-Sotelo, Mayo Clinic, added, "This anatomically contoured dual plating system is designed specifically for treatment of fractures associated with reverse shoulder arthroplasty. It incorporates hooks to brace and support the acromion and is truly a game changer." 

The Equinoxe Scapula Reconstruction System will enter pilot launch with limited availability in the U.S. later this year. For more information, visit www.exac.com.

References

1. K243275, Equinoxe® Scapula Fracture System
2. King JJ, et al. How common are acromial and scapular spine fractures after reverse shoulder arthroplasty?: A systematic review. Bone Joint J. 2019 Jun;101-B(6):627-634. doi: 10.1302/0301-620X.101B6.BJJ-2018-1187.R1.
3. Levy JC, et al. Classification of postoperative acromial fractures following reverse shoulder arthroplasty. J Bone Joint Surg Am. 2013 Aug 7;95(15):e104. doi: 10.2106/JBJS.K.01516. 
4. Boltuch A, et al. Nonoperative treatment of acromial fractures following reverse shoulder arthroplasty: clinical and radiographic outcomes. J Shoulder Elbow Surg. 2022 Jun;31(6S):S44-S56. doi: 10.1016/j.jse.2021.12.024.
5. Ting FSH, et al. Comparing internal fixation constructs for scapular spine insufficiency fractures following reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2021 Jan;30(1):172-177. doi: 10.1016/j.jse.2020.04.051.

About Exactech

Exactech is a global medical technology leader that empowers orthopaedic surgeons with innovative implants, surgical instruments and the Active Intelligence® (AI) ecosystem of smart technologies to give patients EXACTLY what they need to regain mobility. Visit www.exac.com for more information and connect with us on LinkedIn, Vumedi, YouTube, Instagram and X.

SOURCE Exactech, Inc