MedCAD® AccuStride™ System

The MedCAD® AccuStride™ System is software and additive manufacturing equipment that uses CT scan images to create patient-specific surgical guides and anatomical models for preoperative planning and intraoperative guidance of non-acute, non-joint replacing foot osteotomies in patients 12 years and older. The surgical guides are single-use only and designed to assist surgeons in marking bone and positioning surgical instruments.

The system uses CT scan images as input and produces physical surgical guides (made of Ti-6Al-4V ELI titanium or biocompatible polymers) and digital patient-specific case reports as outputs. It employs additive manufacturing for production and achieves a sterility assurance level of 1×10⁻⁶ via steam sterilization by the end-user. The device includes positioning verification guides and anatomical models in addition to surgical guides.

ASTM F1877 was cited for characterizing wear debris generated by cutting and drilling instruments on titanium surgical guides. Sterilization and biocompatibility validation data were leveraged from reference device K223421, with no new testing required in those areas.

The AccuStride™ System shares the same fundamental intended use, principles of operation (software image transfer, manipulation, and surgical planning), and similar technological characteristics (CT image input, physical and digital outputs, titanium construction, similar sterility assurance) as the RedPoint Medical Better Bunion System predicate (K220717). Minor differences in indications for use serve only to clarify appropriate use contexts and do not alter intended use. The addition of positioning verification guides and anatomical models—components already cleared in reference devices K223421 and K223024—is supported by performance testing including cadaver validation and wear debris analysis, which demonstrate no new safety or effectiveness concerns.