Stryker Receives FDA Clearance for Incompass® Total Ankle System

SYK
October 04, 2025

On June 25, 2025, Stryker announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Incompass® Total Ankle System. This implant is specifically intended for patients suffering from ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass system integrates innovative technologies from Stryker’s Inbone® and Infinity® systems into a single, comprehensive solution.

Adam Jacobs, vice president and general manager of Stryker’s Foot & Ankle business, stated that Incompass reflects the company's commitment to redefining total ankle replacement. The system incorporates Adaptis® Boney Ingrowth Technology and redesigned instrumentation to support long-term fixation, surgical flexibility, and streamlined workflow. It is informed by data from over 85,000 CT scans and 100,000 clinical cases.

Developed to address key challenges in total ankle replacement, such as intraoperative adaptability and procedural efficiency, Incompass offers a broad range of implant and instrumentation options for patient-specific care. System enhancements include a redesigned alignment system for greater control, updated implant holders, and refinements designed to reduce surgical steps and setup time, empowering surgeons to deliver more personalized care.

The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.