Stryker has received 510(k) clearance from the FDA for its ShapeMatch Cutting Guides. The cutting guides are single use devices manufactured specifically for each patient based on volumetric data from CT or MRI scans.
ShapeMatch Technology utilizes proprietary 3D imaging software to develop a customized pre-operative surgical plan for each patient. Upon surgeon review and approval, this plan is used to develop cutting guides for the individual patient. ShapeMatch Technology is only available for use with Stryker’s Triathlon Knee System, which has demonstrated the best performance among the most frequently used brands of total knee implants as measured by revision rates in the National Joint Registry of England and Wales.
This technology has the potential to positively impact hospital costs associated with various stages of the patient care continuum during knee surgery.
Press release: Stryker Receives FDA 510(K) Clearance for Shapematch® Cutting Guides …