| K-number | K250923 |
| Device name | Fine Osteotomy |
| Applicant | Bodycad Laboratories, Inc. |
| Product code | HRS |
| Device class | Class II |
| Decision date | Aug 21, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
Fine Osteotomy™ is a patient-specific orthopedic system designed to assist surgeons in planning and performing precise osteotomies (bone cuts) around the knee for treating deformities, fractures, and malalignment from conditions like osteoarthritis. It uses patient imaging data to create 3D models and custom cutting guides (polymer) and titanium fixation implants tailored to individual anatomy.
The system retains identical technological characteristics to its predicate: a patient-specific mechanical fixation solution without an energy source, made of PA 12 polymer cutting guides and Ti-6Al-4V ELI titanium implants. Minor updates expanded compatible components, updated documentation, added software improvements, and enhanced packaging—without altering fundamental design, materials, or operating principles.
Not stated in this summary.
Bodycad argues substantial equivalence because the Fine Osteotomy™ system maintains the same overall design, materials, intended use, and mechanical operating principles as the predicate device K241356. Non-clinical testing (dimensional verification, functional attributes, packaging, and software validation) confirmed the device meets applicable requirements and performs as intended. Since the modifications do not alter the intended use, safety, or effectiveness, and all changes were verified and validated, the device is substantially equivalent.
View the full FDA submission: accessdata.fda.gov