FDA Product Code PBF: Orthopaedic Surgical Planning And Instrument Guides

Patient-specific surgical planning has become a cornerstone of precision orthopedics. FDA product code PBF covers orthopedic surgical planning software and patient-specific instrument guides.

These systems use preoperative CT or MRI data to generate three-dimensional models of the patient's anatomy and custom-fabricated cutting guides that ensure accurate implant positioning. They are used in knee, hip, and shoulder replacement to improve reproducibility of surgical technique.

PBF devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Newclip Technics, Medcad and Materialise NV.