Stryker earns FDA Clearance for new total ankle replacement system

Stryker ankle replacement system receives FDA clearance: ©Stryker

Stryker has received 510(k) clearance from the U.S. Food and Drug Administration for its Incompass Total Ankle System, a next-generation solution for patients suffering from severe ankle joint damage due to rheumatoid, post-traumatic, or degenerative arthritis.

The Incompass system integrates elements from the company’s previous Inbone and Infinity platforms into one streamlined device. The implant incorporates new design features, advanced materials, and enhanced instrumentation aimed at improving surgical efficiency and long-term outcomes for patients.

“Incompass reflects our commitment to redefining what’s possible in total ankle replacement,” said Adam Jacobs, vice president and general manager 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.”

The system was developed using insights from more than 85,000 CT scans and 100,000 clinical cases. Key features include Adaptis Boney Ingrowth Technology to promote long-term fixation, a redesigned alignment system for enhanced control, and a broad range of implant and instrumentation options to better accommodate patient anatomy and surgeon preferences.

Stryker said the platform is intended to support a more adaptable and efficient total ankle replacement procedure while providing tools for personalized surgical planning and execution.

Recent advances in total ankle replacement technology

Total ankle replacement procedures have evolved significantly in recent years, thanks to advancements in biomaterials, imaging technology, and computer-assisted surgical planning.

Modern implants now feature porous surfaces and bone-ingrowth technologies that support biological fixation, improving stability and extending the life of the device. At the same time, CT-based modeling platforms and patient-specific surgical planning tools have improved implant positioning accuracy and reduced intraoperative variability. This has helped surgeons address challenges posed by anatomical diversity and complex arthritic deformities.

The push for customization has led to systems offering modular components and instrumentation tailored to specific patient anatomies. Newer alignment systems also allow for better control in multiple planes, which is particularly beneficial when dealing with prior trauma or abnormal joint alignment. Meanwhile, improvements in surgical workflow—such as pre-assembled instruments and guided cutting jigs—are helping to streamline procedures and reduce operating room time.

As these innovations continue to gain traction, total ankle replacement is becoming a more viable and predictable option for patients previously limited to ankle fusion, offering both pain relief and the preservation of joint mobility.