The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stryker’s Incompass Total Ankle System, designed for individuals whose ankle joints are damaged due to severe rheumatoid, degenerative, or post-traumatic arthritis.

This implant integrates technologies of the company’s Inbone and Infinity systems to offer a comprehensive, unified solution for total ankle replacement.

The system features Adaptis Boney Ingrowth Technology and redesigned instrumentation for supporting long-term fixation and surgical flexibility.

It is said to be tailored for addressing challenges such as intraoperative adaptability and procedural efficiency in ankle replacement surgeries.

Incompass is the result of extensive research, including data from more than 85,000 computed tomography (CT) scans and 100,000 clinical cases.

Developed using the Stryker Orthopaedic Modeling & Analytics (SOMA) platform, the combination of Incompass with arthritic ankle scans from the Prophecy surgical planning system offers implant and instrumentation options, catering to the varying needs of surgeons and the anatomy of patients.

These enhancements include a redesigned alignment system, updated implant holders, and trial tools for better handling, as well as refinements to minimise surgical steps and set-up duration.

Stryker Foot & Ankle business general manager and vice-president Adam Jacobs said: “Incompass reflects our commitment to redefining what’s possible in total ankle replacement.

“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 personalised care with greater efficiency and confidence.”

Stryker provides products across various medical sectors, including MedSurg, neurotechnology, and orthopaedics.

In February this year, the company acquired Inari Medical for a total equity value of nearly $4.9bn, marking a significant expansion into the venous thromboembolism (VTE) market.