FDA Product Code HRS: Plate, Fixation, Bone
FDA product code HRS covers bone fixation plates.
These implants stabilize fractures and osteotomies by bridging and compressing bone segments during healing. They are used across skeletal sites including the hand, wrist, foot, and ankle.
HRS devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include TriMed, Inc., Arthrex, Inc. and Tyber Medical, LLC.
FDA 510(k) Cleared Plate, Fixation, Bone Devices (Product Code HRS)
About Product Code HRS - Regulatory Context
510(k) Submission Activity
1307 total 510(k) submissions under product code HRS since 1976, with 1307 receiving FDA clearance (average review time: 116 days).
Submission volume has increased in recent years - 121 submissions in the last 24 months compared to 78 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for HRS submissions have been consistent, averaging 112 days recently vs 116 days historically.
HRS devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →