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
265–288 of 1322
Cleared Mar 26, 2021
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
K210534
Gramercy Extremity Orthopedics, LLC
Orthopedic · 30d
Cleared Mar 25, 2021
Arthrex Patella SuturePlates
K203834
Arthrex, Inc.
Orthopedic · 85d
Cleared Mar 12, 2021
CoLink Mfx Implant System
K210060
In2bones USA, LLC
Orthopedic · 60d
Cleared Mar 08, 2021
Versalock Periprosthetic Femur Plates System-GMReis
K201728
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 258d
Cleared Mar 03, 2021
LOQTEQ Distal Lateral Femur Plate 4.5 System
K210043
Aap Implantate AG
Orthopedic · 55d
Cleared Mar 02, 2021
Able Medical Devices Valkyrie Thoracic Fixation System
K202889
Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
Orthopedic · 155d
Cleared Feb 24, 2021
ExtremiLOCK Lateral Ankle Fusion Plates
K203479
Osteomed
Orthopedic · 89d
Cleared Feb 22, 2021
Foot and Ankle System
K200062
Leith Medical, LLC
Orthopedic · 406d
Cleared Feb 19, 2021
A.L.P.S. Clavicle Plating System
K210192
Biomet, Inc.
Orthopedic · 25d
Cleared Feb 03, 2021
Arthrex Pilon Fusion System
K203294
Arthrex, Inc.
Orthopedic · 86d
Cleared Jan 28, 2021
Biomet Microfixation RibFix Advantage System
K203474
Biomet Micofixation
Orthopedic · 64d
Cleared Jan 27, 2021
EVOS Large Fragment Plating System
K203405
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Jan 08, 2021
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
K201259
Wrightmedicaltechnologyinc
Orthopedic · 242d
Cleared Dec 29, 2020
Baby Gorilla/Gorilla Plating System
K203511
Paragon 28, Inc.
Orthopedic · 29d
Cleared Dec 16, 2020
DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
K203414
DePuy Synthes
Orthopedic · 27d
Cleared Dec 14, 2020
Javelin Tailor's Bunion Fixation System
K202657
Nvision Biomedical Technologies, Inc.
Orthopedic · 91d
Cleared Nov 24, 2020
PolyLock Plating System
K202959
Fusion Orthopedics, LLC
Orthopedic · 55d
Cleared Nov 20, 2020
Ortho Solutions Plating System
K202764
Ortho Solutions UK , Ltd.
Orthopedic · 60d
Cleared Nov 17, 2020
Activ Fuse
K202307
Newclip Technics
Orthopedic · 95d
Cleared Nov 16, 2020
EVOS Large Fragment Plating System
K201918
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Oct 29, 2020
ANTHEM Fracture System
K202496
Globus Medical, Inc.
Orthopedic · 59d
Cleared Oct 29, 2020
ARIX Ankle Distal Tibia System
K202912
Jeil Medical Corporation
Orthopedic · 30d
Cleared Oct 26, 2020
AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
K202489
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 56d
Cleared Oct 13, 2020
Skeletal Dynamics Ulnar Shortening Plating System
K201962
Skeletal Dynamics, Inc.
Orthopedic · 90d