FDA Product Code HWC: Screw, Fixation, Bone
FDA product code HWC covers bone fixation screws.
These implants are used to stabilize fractures, osteotomies, and bone grafts by compressing bone fragments together or anchoring plates and other fixation constructs. They are available in cortical, cancellous, and cannulated configurations for different anatomical sites and indications.
HWC devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Arthrex, Inc., TriMed, Inc. and Paragon 28, Inc..
FDA 510(k) Cleared Screw, Fixation, Bone Devices (Product Code HWC)
About Product Code HWC - Regulatory Context
510(k) Submission Activity
1055 total 510(k) submissions under product code HWC since 1977, with 1055 receiving FDA clearance (average review time: 115 days).
Submission volume has declined in recent years - 31 submissions in the last 24 months compared to 46 in the prior period.
FDA Review Time
FDA review times for HWC submissions have been consistent, averaging 121 days recently vs 115 days historically.
HWC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →