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
217–240 of 1311
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
Cleared Nov 24, 2021
Xpert Wrist
K213214
Newclip Technics
Orthopedic · 56d
Cleared Nov 18, 2021
CoLink Vallux Plating System
K212487
In2bones USA, LLC
Orthopedic · 101d
Cleared Nov 18, 2021
Stratum® Ankle Fusion Plating System
K212640
Nextremity Solutions, Inc.
General Hospital · 90d
Cleared Oct 18, 2021
LOQTEQ Proximal Humerus Plate 3.5 System
K211582
Aap Implantate AG
Orthopedic · 150d
Cleared Oct 05, 2021
SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System
K203002
Bonebridge AG
Orthopedic · 369d
Cleared Oct 01, 2021
Anthem Fracture System
K212433
Globus Medical, Inc.
Orthopedic · 58d
Cleared Sep 21, 2021
GEO Extremity and Ankle Plating System
K212334
Gramercy Extremity Orthopedics, LLC
Orthopedic · 56d
Cleared Aug 20, 2021
Omni Foot and Ankle Plating System
K212297
Extremity Medical, LLC
Orthopedic · 29d
Cleared Aug 13, 2021
Tyber Medical Anatomical Plating System
K203817
Tyber Medical, LLC
Orthopedic · 227d
Cleared Jul 30, 2021
Summit Patella Plating System
K203408
Endeavor Orthopaedics, LLC
Orthopedic · 253d
Cleared Jul 28, 2021
FINE Osteotomy
K211646
Bodycad Laboratories, Inc.
Orthopedic · 61d