FDA Product Code PLF: Bone Wedge
FDA product code PLF covers bone wedges used as grafts or spacers in orthopedic procedures.
These shaped bone or synthetic spacers are used with ancillary fixation to correct angular deformities, restore joint alignment, and fill bone defects created during corrective osteotomies and revision surgery. They are commonly used in high tibial osteotomy and distal femoral osteotomy.
PLF devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Nvision Biomedical Technologies, Inc., Nvision Biomedical Technologies and Paragon 28, Inc..
FDA 510(k) Cleared Bone Wedge Devices (Product Code PLF)
About Product Code PLF - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code PLF since 2015, with 18 receiving FDA clearance (average review time: 121 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PLF have taken an average of 139 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.
PLF devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →