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 Bodycad Laboratories, Inc..
FDA 510(k) Cleared Orthopaedic Surgical Planning And Instrument Guides Devices (Product Code PBF)
About Product Code PBF - Regulatory Context
510(k) Submission Activity
27 total 510(k) submissions under product code PBF since 2012, with 27 receiving FDA clearance (average review time: 230 days).
Submission volume has remained relatively stable over the observed period, with 10 submissions in the last 24 months.
FDA Review Time
FDA review times for PBF submissions have been consistent, averaging 227 days recently vs 231 days historically.
PBF devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →