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 TriMed, Inc., Arthrex, Inc. and Tyber Medical, LLC.

1307
Total
1307
Cleared
116d
Avg days
1976
Since
1307 devices
169–192 of 1307
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 May 27, 2022
CoLink PCR Plating System
K213698
In2bones USA, LLC
Orthopedic · 185d
Cleared May 17, 2022
SternaLock Sternal Closure System
K212782
Biomet Microfixation
Orthopedic · 258d
Cleared May 02, 2022
Arthrx Fracture Plates
K213837
Arthrex, Inc.
Orthopedic · 144d
Cleared Apr 22, 2022
RibFix Blu Thoracic Fixation System
K212608
Biomet Microfixation
Orthopedic · 248d
Cleared Mar 11, 2022
Pectus Support Bar System
K213712
Biomet Microfixation
Orthopedic · 107d
Cleared Mar 02, 2022
Medline UNITE Calcaneal Fracture Plating System
K213567
Medline Industries, LP
Orthopedic · 113d
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 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 Oct 18, 2021
LOQTEQ Proximal Humerus Plate 3.5 System
K211582
Aap Implantate AG
Orthopedic · 150d
Cleared Oct 01, 2021
Anthem Fracture System
K212433
Globus Medical, Inc.
Orthopedic · 58d
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 27, 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
K210016
Integra LifeSciences Corporation
Orthopedic · 204d