Stryker receives FDA clearance for Additive Manufacturing-enabled Incompass Total Ankle System
Stryker, headquartered in Portage, Michigan, USA, has received US Food and Drug Administration (FDA) 510(k) clearance for its Incompass Total Ankle System, an implant designed for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The new Incompass platform integrates the technologies of Stryker’s Inbone and Infinity systems into a single solution for total ankle replacement. It adopts the company’s Adaptis Boney Ingrowth Technology and redesigned instrumentation to support long-term fixation, surgical flexibility and streamlined workflow. The Adaptis technology uses metal Additive Manufacturing to create a scaffold that facilitates bone ingrowth.
“Incompass reflects our commitment to redefining what’s possible in total ankle replacement,” stated 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 personalised care with greater efficiency and confidence.”
Developed to address challenges in total ankle replacement, including intraoperative adaptability and procedural efficiency, the system is said to be informed by data from more than 85,000 CT scans and 100,000 clinical cases. It also offers a range of implant and instrumentation options to support patient-specific care.
Built using the 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 instrument options designed to accommodate both surgeon preference and patient anatomy. 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.
