FDA Product Code HTY: Pin, Fixation, Smooth
FDA product code HTY covers smooth fixation pins used in orthopedic and trauma surgery.
These thin, smooth Kirschner wires and Steinmann pins are used to temporarily or definitively stabilize fracture fragments, guide cannulated screws, and fix small bones of the hand, wrist, and foot. Their smooth surface allows removal without disrupting surrounding tissue after healing.
HTY devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include OrthoPediatrics Corp., OSSIO , Ltd. and Biomet, Inc..
FDA 510(k) Cleared Pin, Fixation, Smooth Devices (Product Code HTY)
About Product Code HTY - Regulatory Context
510(k) Submission Activity
204 total 510(k) submissions under product code HTY since 1977, with 204 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.
FDA Review Time
Recent submissions under HTY have taken an average of 82 days to reach a decision - down from 115 days historically, suggesting improved FDA processing for this classification.
HTY devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →