HRS · Class II · 21 CFR 888.3030

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 Synthes (Usa), Wrightmedicaltechnologyinc and Arthrex, Inc..

1311
Total
1311
Cleared
116d
Avg days
1976
Since
1311 devices
193–216 of 1311
Cleared Aug 24, 2022
ARIX Small Fragment System
K221920
Jeil Medical Corporation
Orthopedic · 54d
Cleared Aug 19, 2022
Baby Gorilla®/Gorilla® Plating System
K222194
Paragon 28, Inc.
Orthopedic · 28d
Cleared Jul 08, 2022
Stryker VariAx 2 MIS Calcaneus
K221346
Stryker GmbH
Orthopedic · 60d
Cleared Jul 01, 2022
Footmotion Plating System
K221395
Newclip Technics
Orthopedic · 49d
Cleared Jun 29, 2022
Arthrex Mini Fragment System
K220937
Arthrex, Inc.
Orthopedic · 90d
Cleared Jun 17, 2022
Baby Gorilla/Gorilla Plating System
K221465
Paragon 28, Inc.
Orthopedic · 29d
Cleared Jun 10, 2022
Omni Foot and Ankle Plating System
K221362
Exremity Medical, LLC
Orthopedic · 30d
Cleared May 27, 2022
CoLink PCR Plating System
K213698
In2bones USA, LLC
Orthopedic · 185d
Cleared May 20, 2022
CalcShift™ Displacement Calcaneal Osteotomy System
K212979
Nextremity Solutions, Inc.
Orthopedic · 245d
Cleared May 18, 2022
Osteotomy Truss System (OTS)
K220463
4Web Medical, Inc.
Orthopedic · 90d
Cleared May 17, 2022
SternaLock Sternal Closure System
K212782
Biomet Microfixation
Orthopedic · 258d
Cleared May 02, 2022
ALPHALOK™ Plating System
K212348
Vilex, LLC
Orthopedic · 278d
Cleared May 02, 2022
Arthrx Fracture Plates
K213837
Arthrex, Inc.
Orthopedic · 144d
Cleared Apr 28, 2022
DVR® Crosslock Wrist Spanning Plate (131849181)
K220244
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
Orthopedic · 90d
Cleared Apr 22, 2022
RibFix Blu Thoracic Fixation System
K212608
Biomet Microfixation
Orthopedic · 248d
Cleared Apr 05, 2022
DRPx Locking Distal Radius Plate System
K212601
Orthopaedic Implant Company
Orthopedic · 231d
Cleared Mar 21, 2022
AFFINITY Proximal Tibia System
K220199
Techfit Digital Surgery, Inc.
Orthopedic · 56d
Cleared Mar 14, 2022
2.4mm Distal Radius System
K211324
Auxein Medical Private Limited
Orthopedic · 318d
Cleared Mar 11, 2022
Intai Anatomic Locking Plate and Screw System
K201229
Intai Technology Corporation
Orthopedic · 673d
Cleared Mar 11, 2022
Apollo Ankle Fracture Plating System
K213005
Glw Medical, Inc.
Orthopedic · 172d
Cleared Mar 11, 2022
Pectus Support Bar System
K213712
Biomet Microfixation
Orthopedic · 107d
Cleared Mar 04, 2022
PolyLock Plating System
K211843
Fusion Orthopedics
Orthopedic · 262d
Cleared Mar 02, 2022
Medline UNITE Calcaneal Fracture Plating System
K213567
Medline Industries, LP
Orthopedic · 113d
Cleared Feb 23, 2022
Arsenal Ankle Plating System
K212378
Trilliant Surgical
Orthopedic · 205d