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., Wrightmedicaltechnologyinc and Synthes (Usa).
FDA 510(k) Cleared Screw, Fixation, Bone Devices (Product Code HWC)
About Product Code HWC - Regulatory Context
510(k) Submission Activity
1070 total 510(k) submissions under product code HWC since 1977, with 1070 receiving FDA clearance (average review time: 115 days).
Submission volume has remained relatively stable over the observed period, with 38 submissions in the last 24 months.
FDA 510(k) Review Time - HWC Product Code
FDA review times for HWC submissions have been consistent, averaging 125 days recently vs 115 days historically.
HWC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →