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
121–144 of 1311
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
Cleared Mar 21, 2024
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
K233665
DePuy Synthes
Orthopedic · 127d
Cleared Mar 21, 2024
APTUS Hand Scaphoid Plates
K234062
Medartis AG
Orthopedic · 90d
Cleared Feb 22, 2024
Treace Medical Systems (TMC) Plating System
K240173
Treace Medical Concepts, Inc.
Orthopedic · 30d
Cleared Jan 19, 2024
HKT Anatomical Locking Trauma System
K231213
Hankil Tech Medical Co., Ltd.
Orthopedic · 266d
Cleared Jan 18, 2024
Medline UNITE Ancillary Foot Recon Plating System
K234031
Medline Industires, LP
Orthopedic · 29d
Cleared Jan 12, 2024
Quick - Radius Disposable Set
K231684
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 217d
Cleared Dec 21, 2023
SkyOPS™ Orthopedic Plate System
K233154
Sky Surgical, LLC
Orthopedic · 85d
Cleared Dec 21, 2023
Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System
K233423
Tyber Medical, LLC
Orthopedic · 72d
Cleared Dec 20, 2023
TM Plating System
K233017
Tyber Medical, LLC
Orthopedic · 89d
Cleared Dec 15, 2023
Internal Locking Plate and Screw Fixation System
K232394
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Orthopedic · 128d
Cleared Dec 14, 2023
ARIX Ankle Distal Tibia System
K231887
Jeil Medical Corporation
Orthopedic · 170d