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
121–144 of 1322
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
Cleared Jun 20, 2024
APTUS Elbow Dorsal Olecranon Plates
K240613
Medartis AG
Orthopedic · 107d
Cleared Jun 11, 2024
SIGNEX
K230546
Osteonic Co., Ltd.
Orthopedic · 469d
Cleared Jun 05, 2024
Baby Gorilla/Gorilla Plating System
K241262
Paragon 28, Inc.
Orthopedic · 30d
Cleared May 31, 2024
Tyber Medical Anatomical Plating System
K241218
Tyber Medical, LLC
Orthopedic · 30d
Cleared May 24, 2024
NeoSpan® Compression Implant System
K233089
In2bones USA, LLC
Orthopedic · 241d
Cleared May 09, 2024
DePuy Synthes MatrixSTERNUM Fixation System
K233967
Synthes GmbH
Orthopedic · 146d
Cleared Apr 26, 2024
XLO Brand of Locking Distal Humerus Plating System
K233873
Ortho Life Systems Private Limited
Orthopedic · 141d
Cleared Apr 22, 2024
Acumed Wrist Plating System
K233311
Acumed, LLC
Orthopedic · 206d
Cleared Apr 19, 2024
APTUS Foot System 2.8-3.5
K232105
Medartis AG
Orthopedic · 280d
Cleared Apr 17, 2024
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-
K233863
TriMed, Inc.
Orthopedic · 133d
Cleared Apr 12, 2024
Fine Osteotomy™
K240703
Bodycad Laboratories, Inc.
Orthopedic · 29d
Cleared Apr 05, 2024
TDM Large Bone Plate and Screw System
K232115
Tdm Co., Ltd.
Orthopedic · 266d
Cleared Mar 25, 2024
VariAx 2 Distal Radius System
K233919
Stryker GmbH
Orthopedic · 103d