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
313–336 of 1311
Cleared Jan 10, 2020
MotoBAND CP Implant System
K193452
Crossroads Extemity Systems, LLC
Orthopedic · 28d
Cleared Jan 05, 2020
TriMed ASET Foot Plating System
K192696
TriMed, Inc.
Orthopedic · 101d
Cleared Dec 23, 2019
Mini and Micro Fragments Reconstruction System – GMReis
K182718
Gm Dos Reis Industria E Comerico Ltda.
Orthopedic · 451d
Cleared Dec 14, 2019
Airlock Centrolock Osteosynthesis Implant System
K192356
Novastep
Orthopedic · 107d
Cleared Dec 13, 2019
Avanti Distal Radius and Forearm System
K191118
Avanti Orthopaedics, Inc.
Orthopedic · 231d
Cleared Dec 09, 2019
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System
K191793
Nebula Surgical Private Limited
Orthopedic · 159d
Cleared Dec 03, 2019
Exsomed Wrist Plating System
K192473
Exsomed Corporation
Orthopedic · 84d
Cleared Nov 22, 2019
VariAx Foot
K192675
Stryker GmbH
Orthopedic · 57d
Cleared Nov 21, 2019
Axis Plating System
K192592
Extremity Medical, LLC
Orthopedic · 62d
Cleared Nov 18, 2019
PolyLock Small Bone Plating System
K192323
Fusion Orthopedics, LLC
Orthopedic · 83d
Cleared Nov 15, 2019
TDM Plate and Screw Systems
K190391
Tdm Co., Ltd.
Orthopedic · 269d
Cleared Nov 12, 2019
ARIX Wrist System
K191972
Jeil Medical Corporation
Orthopedic · 111d
Cleared Nov 08, 2019
APTUS Wrist Arthrodesis Plates
K192297
Medartis AG
Orthopedic · 77d
Cleared Nov 07, 2019
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
K192327
Synthes USA Products, LLC
Orthopedic · 72d
Cleared Oct 30, 2019
Treace Medical Concepts (TMC) Plating System
K192504
Treace Medical Concepts, Inc.
Orthopedic · 48d
Cleared Oct 16, 2019
Arthrex Minimally Invasive Ankle Fusion Plate
K190953
Arthrex, Inc.
Orthopedic · 188d
Cleared Oct 15, 2019
Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module
K191326
Arthrex, Inc.
Orthopedic · 152d
Cleared Oct 03, 2019
Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
K191344
Arthrex, Inc.
Orthopedic · 136d
Cleared Sep 30, 2019
APTUS Wrist Spanning Plates 2.5
K191848
Medartis AG
Orthopedic · 82d
Cleared Sep 16, 2019
AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws
K191641
Industrias Medicas Sampedro S.A.S
Orthopedic · 89d
Cleared Sep 13, 2019
NCB Plating System Distal Femur and Proximal Tibia
K192217
Zimmer GmbH
Orthopedic · 29d
Cleared Aug 23, 2019
VariAx 2 System, VariAx 2 Mini Fragment System
K191412
Stryker GmbH
Orthopedic · 87d
Cleared Aug 22, 2019
NCB Polyaxial Locking Plate System
K192021
Zimmer GmbH
Orthopedic · 24d
Cleared Aug 12, 2019
Arsenal Plating System
K191009
Trilliant Surgical
Orthopedic · 118d