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
97–120 of 1311
Cleared Nov 01, 2024
Osteotomy Truss System (OTS)
K240388
4Web Medical, Inc.
Orthopedic · 267d
Cleared Oct 31, 2024
Bonebridge Osteosynthesis Plating System
K242399
Bonebridge AG
Orthopedic · 79d
Cleared Oct 23, 2024
OIC Small / Mini Fragment Plate System
K242995
The Orthopaedic Implant Company
Orthopedic · 27d
Cleared Oct 21, 2024
Arthrex VAL and VAL KreuLock™ Compression Screw System
K242554
Arthrex, Inc.
Orthopedic · 55d
Cleared Oct 09, 2024
Clavicle and Scapula System
K240181
Auxein Medical Pvt., Ltd.
Orthopedic · 260d
Cleared Oct 06, 2024
Pangea Platform
K242445
Stryker GmbH
Orthopedic · 51d
Cleared Oct 04, 2024
BPS Wrist Fracture System
K242343
Orthonovis, Inc.
Orthopedic · 58d
Cleared Sep 26, 2024
Protean Fragment Plating System
K241815
Skeletal Dynamics, Inc.
Orthopedic · 94d
Cleared Sep 19, 2024
Pectus Blu Support Bar System
K241709
Biomet Microfixation
Orthopedic · 98d
Cleared Sep 17, 2024
TriMed Bridge Plates
K241942
TriMed, Inc.
Orthopedic · 77d
Cleared Sep 05, 2024
Fine Osteotomy™
K241356
Bodycad Laboratories, Inc.
Orthopedic · 114d
Cleared Sep 03, 2024
EVOS Patella Plates
K240487
Smith & Nephew
Orthopedic · 196d
Cleared Aug 28, 2024
REDEMPTION Charcot Plating System
K233816
Vilex, LLC
Orthopedic · 272d
Cleared Aug 23, 2024
SITTER 3.5mm Versatile System
K240318
Bonebridge AG
Orthopedic · 203d
Cleared Aug 19, 2024
RibFix Titan™ Fixation System
K241282
Riverpoint Medical
Orthopedic · 104d
Cleared Aug 15, 2024
NCB® Polyaxial Locking Plate System
K241754
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 58d
Cleared Aug 13, 2024
CoLink NeoFuse MIS Plating System (see attached parts list)
K241387
In2bones USA
Orthopedic · 90d
Cleared Aug 01, 2024
Freefix Forearm Plating System
K242055
Skeletal Dynamics, Inc.
Orthopedic · 17d
Cleared Jul 30, 2024
Activmotion S
K241539
Newclip Technics
Orthopedic · 60d
Cleared Jul 26, 2024
VOLT™ Proximal Humerus 3.5 Plating System
K233994
Synthes GmbH
Orthopedic · 221d
Cleared Jul 23, 2024
Gaudi Proximal Humerus Plate
K241296
Netbiologics, LLC
Orthopedic · 76d
Cleared Jul 12, 2024
KLS Martin Orthopedic Implants - MR Conditional
K241018
KLS-Martin L.P.
Orthopedic · 88d
Cleared Jun 26, 2024
Versalock Rib and Sternum Plates System
K232829
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 287d
Cleared Jun 26, 2024
Forma Medical Optimal Plating System
K234059
Forma Medical, Inc.
Orthopedic · 187d