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
97–120 of 1322
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
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