Stryker (NYSE: SYK) announced FDA 510(k) clearance for its Incompass Total Ankle Replacement System, designed for patients with ankle damage caused by severe rheumatoid, post-traumatic, or degenerative arthritis.
The Portage, Michigan-based company developed Incompass by integrating features from its Inbone and Infinity systems into one platform, focusing on long-term fixation, surgical flexibility, and streamlined workflows. The system leverages Adaptis boney ingrowth technology and updated instrumentation to enhance procedural control and efficiency.
Using data from over 85,000 CT scans and 100,000 clinical cases, combined with its SOMA (Orthopaedic Modeling & Analytics) platform and Prophecy Surgical Planning System, Stryker tailored Incompass for patient-specific care.
Key enhancements include a redesigned multi-plane alignment system, improved implant holders, trial tools, and refined instrumentation to support surgeon preference and complex anatomies.
“Incompass represents a new standard in total ankle replacement, enabling personalized care with greater efficiency,” said Adam Jacobs, VP and GM, Foot & Ankle at Stryker.
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