BETHLEHEM, PA, UNITED STATES, October 15, 2025 /EINPresswire.com/ — EXALTA Group, a global leader in the development and manufacturing of integrated OEM solutions for mission-critical medical devices, today announced it has obtained European Medical Device Regulation (EU-MDR) certification for its full range of headed and headless titanium compression screws used in trauma and reconstructive surgery.
This certification enables EXALTA’s OEM partners to commercialize these proven platforms across Europe, providing surgeons and patients broader access to high-performance fixation systems. Developed to meet the demands of modern trauma and reconstructive procedures, the portfolio covers indications including bone reconstruction, osteotomy, arthrodesis, joint fusion, and fracture fixation.
EXALTA’s compression screw systems combine strength, precision, and simplicity. Offered in diameters from 1.5 mm to 9.0 mm, and available in headed or headless configurations, they are manufactured in titanium with short, long, or full thread options. A cannulated design ensures accurate K-wire insertion, while self-drilling and self-tapping features streamline placement. Supplied in sterile or non-sterile packaging, the systems deliver consistent performance and ease of use in diverse surgical settings.
“Achieving EU-MDR certification for our compression screw systems underscores EXALTA’s commitment to regulatory excellence and patient safety,” said Lisa Boyle, Vice President of Regulatory Affairs at EXALTA Group. “This certification validates the quality and performance of our devices and accelerates our partners’ ability to bring these technologies to European surgeons and patients faster. Our teams continue to deliver on EXALTA’s promise of combining robust compliance with speed-to-market.”
While EXALTA’s technology platforms are exclusively marketed under its customers’ brands, the EXALTA team will make its debut at the Orthopaedic Trauma Association (OTA) Annual Meeting, Booth #129, October 15–18 in Phoenix, AZ, to connect with OEM partners and explore new opportunities to fast-track innovation and expand global access to advanced trauma solutions.
About EXALTA Group
With operations across multiple continents, EXALTA Group is a global solutions provider for the MedTech industry. Through its Manufacturing Solutions and Integrated OEM Solutions business units, the company supports leading OEMs in delivering breakthrough medical devices that improve patient outcomes worldwide. Learn more at exalta.com
Francois Samson
EXALTA
+1 901-647-1304
fsamson@exalta.com
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