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
73–96 of 1307
Cleared Mar 07, 2025
APTUS Hand System
K243610
Medartis AG
Orthopedic · 105d
Cleared Feb 27, 2025
CastleLoc Pectus Bar System
K243357
L & K Biomed Co., Ltd.
Orthopedic · 121d
Cleared Feb 19, 2025
EVOS Pelvic and Acetabular System
K241666
Smith & Nephew
Orthopedic · 254d
Cleared Feb 19, 2025
A.L.P.S. Small Fragment Plating System
K243761
Biomet Orthopedics
Orthopedic · 75d
Cleared Feb 10, 2025
Locking Plates and Screws Systems
K240958
Hebei Ruihe Medical Devices Co., Ltd.
Orthopedic · 308d
Cleared Feb 06, 2025
Signature Osteosynthesis Plate System
K241599
Signature Orthopaedic Pty , Ltd.
Orthopedic · 247d
Cleared Feb 06, 2025
BPS - Bone Fragment Fixation Plates, Screws and Washers
K250055
Orthonovis, Inc.
Orthopedic · 27d
Cleared Jan 29, 2025
Versalock Upper Limb Plating System
K243740
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 56d
Cleared Jan 15, 2025
TriMed Wrist Fixation System (Volar Bearing Plates)
K243569
TriMed, Inc.
Orthopedic · 58d
Cleared Dec 23, 2024
ARTFX Trauma Bone Plate and Screw System
K242939
Artfx Medical
Orthopedic · 89d
Cleared Dec 20, 2024
Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
K243308
Bonebridge AG
Orthopedic · 60d
Cleared Dec 11, 2024
SternalPlate Expansion
K243491
Stryker Leibinger GmbH & Co KG
Orthopedic · 29d
Cleared Dec 05, 2024
TDM Plate and Screw System
K241128
Tdm Co., Ltd.
Orthopedic · 225d
Cleared Nov 26, 2024
HyperFlex™ Bunion Correction System
K241995
Footbridge Medical
Orthopedic · 140d
Cleared Nov 26, 2024
TriMed Posterior Malleolus Fixation System
K243050
TriMed, Inc.
Orthopedic · 60d
Cleared Nov 21, 2024
Versalock Mini and Micro Plating System
K242596
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 83d
Cleared Nov 21, 2024
GMReis Ankle Plating System
K242998
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 56d
Cleared Nov 14, 2024
Arthrex Elbow Fracture Plating System
K242079
Arthrex, Inc.
Orthopedic · 121d
Cleared Nov 14, 2024
Proximal Humerus Fixation System
K242436
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared Nov 14, 2024
Tandry Q-Locking Plate System
K242814
Microware Precision Co., Ltd.
Orthopedic · 57d
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