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
361–384 of 1322
Cleared Apr 19, 2019
ATLAS Plating System
K190415
MiRus, LLC
Orthopedic · 57d
Cleared Apr 12, 2019
Baby Gorilla/Gorilla Plating System
K190365
Paragon 28, Inc.
Orthopedic · 56d
Cleared Apr 12, 2019
MIS Bunion Plating System
K190658
Crossroads Extremity Systems, LLC
Orthopedic · 29d
Cleared Mar 11, 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
K190253
Smith & Nephew, Inc.
Orthopedic · 32d
Cleared Mar 05, 2019
Stryker SternalPlate System
K183172
Stryker
Orthopedic · 109d
Cleared Mar 04, 2019
MLP Special Locking Bone Plate System
K181843
Maxxion Medical, LLC / Baumer SA
Orthopedic · 236d
Cleared Feb 19, 2019
MIS Bunion System
K181872
Crossroads Extremity Systems, LLC
Orthopedic · 222d
Cleared Feb 14, 2019
AdvantageRib System
K183317
Sig Medical Corporation
Orthopedic · 76d
Cleared Feb 13, 2019
EPIC Extremity Fusion Plate System
K182991
Epic Extremity, LLC
Orthopedic · 107d
Cleared Jan 25, 2019
Treace Medical Concepts (TMC) Plating System
K183321
Treace Medical Concepts, Inc.
Orthopedic · 56d
Cleared Jan 10, 2019
Additive Orthopaedics Patient Specific 3D Locking Lattice Plates
K183011
Additive Orthopaedics
Orthopedic · 71d
Cleared Dec 26, 2018
DePuy Synthes Trauma Orthopedic Nail Implants
K182783
DePuy Synthes
Orthopedic · 86d
Cleared Dec 21, 2018
TruMatch Graft Cage - Long Bone
K180821
Synthes (Usa), LLC
Orthopedic · 266d
Cleared Dec 10, 2018
Distal Radius Plating System
K182810
Miami Device Solutions, LLC
Orthopedic · 68d
Cleared Nov 20, 2018
ARIX Sternal System
K181806
Jeil Medical Corporation
Orthopedic · 137d
Cleared Nov 16, 2018
AdvantageRib Anterior System
K182179
Sig Medical Corp.
Orthopedic · 95d
Cleared Nov 16, 2018
Stratum™ Foot Plating System
K182201
Nextremity Solutions, Inc.
Orthopedic · 94d
Cleared Nov 01, 2018
DePuy Synthes Trauma Orthopedic Plates and Screws
K180310
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Orthopedic · 269d
Cleared Nov 01, 2018
Medline Unite Mini Plates and Screws
K181820
Medline Industries, Inc.
Orthopedic · 115d
Cleared Oct 30, 2018
AOS Calcaneal Plating System
K182466
Advanced Orthopaedic Solutions
Orthopedic · 50d
Cleared Oct 22, 2018
ANTHEM Fracture System
K180554
Globus Medical, Inc.
Orthopedic · 235d
Cleared Oct 19, 2018
Titanium TomoFix Medial High Tibia Plate Anatomical
K180213
Synthes USA Products, LLC
Orthopedic · 267d
Cleared Oct 11, 2018
AxSOS 3 Ti
K181091
Stryker GmbH
Orthopedic · 170d
Cleared Oct 11, 2018
Piccolo Composite® Plate System
K182015
CarboFix Orthopedics , Ltd.
Orthopedic · 76d