Stryker has earned U.S. Food and Drug Administration (FDA) 510(k) for its Incompass total ankle system.

The implant is intended for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Incompass integrates the company’s Inbone and Infinity systems into one comprehensive solution for total ankle replacement.

The ankle system features Adaptis bony ingrowth technology and redesigned instrumentation. It was developed to address the challenges of intraoperative adaptability and procedural efficiency in total ankle replacement—Incompass was informed by data from over 85,000 CT scans and 100,000 clinical cases.

To support patient-specific care, it also offers a broad range of implant and instrumentation options.

Incompass was built using Stryker’s Orthopaedic Modeling & Analytics (SOMA) platform in combination with arthritic ankle scans from the company’s Prophecy Surgical Planning System. System enhancements include a redesigned alignment system for greater control across multiple planes, updated implant holders and trial tools for improved handling, and instrumentation refinements designed to reduce surgical steps and set up time.

“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.”

Last month, the company earned FDA clearance for its OptaBlate basivertebral nerve ablation system (OptaBlate BVN). The technology is used in a targeted, minimally invasive surgery that can provide long-lasting vertebrogenic pain relief.