| K-number | K252064 |
| Device name | MedCAD® AccuStride System |
| Applicant | Medcad |
| Product code | PBF |
| Device class | Class II |
| Decision date | Mar 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The MedCAD® AccuStride™ System is a software and additive manufacturing system that assists in preoperative planning and surgical guidance for non-acute, non-joint replacing bone surgeries (osteotomies) in the foot, ankle, and lower leg for patients 12 years and older. It produces patient-specific surgical guides, anatomical models, and case reports from CT imaging data.
The device is identical to its predicate in component design, geometry, materials (biocompatible polymers and Ti-6Al-4V ELI titanium), sterilization method (steam sterilized by end-user), software, and manufacturing process (additive manufacturing). The only difference is expanded anatomical indications to include ankle and lower leg (tibia/fibula) in addition to the foot.
Not stated in this summary. The document mentions ISO 13485 requirements for quality management but does not cite specific device performance test standards or consensus standards.
The MedCAD® AccuStride™ System is substantially equivalent to its predicate (K241811) because there are no differences in principle of operation, inputs, outputs, materials, sterilization, or software—only an expansion of indicated anatomical locations. Cadaver validation testing confirmed surgical guides met predetermined acceptance criteria across representative osteotomy locations.
View the full FDA submission: accessdata.fda.gov