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..

1322
Total
1322
Cleared
116d
Avg days
1976
Since
1322 devices
217–240 of 1322
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
Cleared Feb 18, 2022
Traufix osteosynthesis, osteotomy, and arthrodesis devices
K201510
Fixier S.A. DE C.V.
Orthopedic · 623d
Cleared Feb 16, 2022
Treace Medical Concepts (TMC) Plating System
K220136
Treace Medical Concepts, Inc.
Orthopedic · 29d
Cleared Feb 11, 2022
FlexitSystem Knee osteotomy system
K212545
Neosteo
Orthopedic · 183d
Cleared Jan 27, 2022
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
K213489
Wishbone Medical, Inc.
Orthopedic · 87d
Cleared Jan 26, 2022
SternaFuse Fixation System
K202914
Fusion Innovations, LLC
Orthopedic · 484d
Cleared Jan 26, 2022
ANTHEM® Fracture System
K213591
Globus Medical, Inc.
Orthopedic · 75d
Cleared Jan 19, 2022
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
K212581
Stryker GmbH
Orthopedic · 156d
Cleared Jan 13, 2022
Distal Humerus Plating System
K213895
Skeletal Dynamics, Inc.
Orthopedic · 30d
Cleared Jan 07, 2022
GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive
K210198
Gpc Medical Limited
Orthopedic · 347d
Cleared Jan 07, 2022
Pectus Blu Support Bar System
K212841
Biomet Micofixation
Orthopedic · 122d
Cleared Dec 16, 2021
Activmotion S DTO
K202803
Newclip Technics
Orthopedic · 449d
Cleared Dec 13, 2021
CoLink NeoFuse Plating System
K213069
In2bones USA, LLC
Orthopedic · 81d
Cleared Nov 24, 2021
The Radian MIS Bunion System
K211650
Nvision Biomedical Technologies, Inc.
Orthopedic · 180d