Stryker (NYSE: SYK) announced today that it received FDA 510(k) clearance for its Incompass total ankle system.
Portage, Michigan-based Stryker designed the implant for patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis. The company says its new platform integrates the technologies of its Inbone and Infinity systems into a single, comprehensive total ankle replacement system.
Incompass incorporates the company’s Adaptis boney ingrowth technology and redesigned instrumentation. It supports long-term fixation, surgical flexibility and streamlined workflows.
Stryker developed the implant to address key challenges in total ankle replacement, including interoperative adaptability and procedural efficiency. It used data from more than 85,000 CT scans and 100,000 clinical cases to inform the system. Stryker also offers a broad range of implant and instrumentation options to support patient-specific care.
The company built its system using its Stryker Orthopaedic Modeling & Analytics (SOMA) platform in combination with arthritic ankle scans from the company’s Prophecy Surgical Planning System. Incompass provides a continuum of implant and instrumentation options to accommodate surgeon preference and patient anatomy.
Enhancements include a redesigned alignment system for greater control across multiple planes. It also features updated implant holders and trial tools for improved handling, as well as instrumentation refinements.
“Incompass reflects our commitment to redefining what’s possible in total ankle replacement,” said Adam Jacobs, VP and GM of Stryker’s Foot & Ankle business. “By building on decades of clinical experience and leveraging extensive data insights, we’re setting a new standard — one that empowers surgeons to deliver more personalized care with greater efficiency and confidence.”
