ClearanceBrief
Panels › Orthopedic › Product code HRS · Class 2

Plate, Fixation, Bone

Regulation 888.3030

62510(k)s in 12 months (1,332 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
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Top companies in HRS

Company510(k)sRecalls
Synthes1048
Smith & Nephew3716
Biomet2128
Wrightmedicaltechnologyinc450
Zimmer GmbH3212
Wright Medical Technology Inc043
Arthrex, Inc.393
DePuy Orthopaedics, Inc.1814
Medartis AG320
TriMed, Inc.256
Decided510(k)Device and applicantCode
Feb 19, 2025K241666EVOS Pelvic and Acetabular System
Smith & Nephew
HRS
Feb 10, 2025K240958Locking Plates and Screws Systems
Hebei Ruihe Medical Devices Co., Ltd., CN
HRS
Feb 6, 2025K250055BPS - Bone Fragment Fixation Plates, Screws and Washers
Orthonovis, Inc.
HRS
Feb 6, 2025K241599Signature Osteosynthesis Plate System
Signature Orthopaedic Pty , Ltd., AU
HRS
Jan 29, 2025K243740Versalock Upper Limb Plating System
GM Dos Reis Industria e Comercio Ltda., BR
HRS
Jan 15, 2025K243569TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wri
TriMed, Inc.
HRS
Dec 23, 2024K242939ARTFX Trauma Bone Plate and Screw System
Artfx Medical
HRS
Dec 20, 2024K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, L
Bonebridge AG, CH
HRS
Dec 11, 2024K243491SternalPlate Expansion
Stryker Leibinger GmbH & Co KG, DE
HRS
Dec 5, 2024K241128TDM Plate and Screw System
Tdm Co., Ltd., KR
HRS
Nov 26, 2024K243050TriMed Posterior Malleolus Fixation System
TriMed, Inc.
HRS
Nov 26, 2024K241995HyperFlex™ Bunion Correction System
Footbridge Medical
HRS
Nov 21, 2024K242998GMReis Ankle Plating System
GM Dos Reis Industria e Comercio Ltda., BR
HRS
Nov 21, 2024K242596Versalock Mini and Micro Plating System
GM Dos Reis Industria e Comercio Ltda., BR
HRS
Nov 14, 2024K242814Tandry Q-Locking Plate System
Microware Precision Co., Ltd., TW
HRS
Nov 14, 2024K242436Proximal Humerus Fixation System
Skeletal Dynamics, Inc.
HRS
Nov 14, 2024K242079Arthrex Elbow Fracture Plating System
Arthrex, Inc.
HRS
Nov 1, 2024K240388Osteotomy Truss System (OTS)
4Web Medical, Inc.
HRS
Oct 31, 2024K242399Bonebridge Osteosynthesis Plating System
Bonebridge AG, CH
HRS
Oct 23, 2024K242995OIC Small / Mini Fragment Plate System
The Orthopaedic Implant Company
HRS
Oct 21, 2024K242554Arthrex VAL and VAL KreuLock™ Compression Screw System
Arthrex, Inc.
HRS
Oct 9, 2024K240181Clavicle and Scapula System
Auxein Medical Pvt., Ltd., IN
HRS
Oct 6, 2024K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
Stryker GmbH, CH
HRS
Oct 4, 2024K242343BPS Wrist Fracture System
Orthonovis, Inc.
HRS
Sep 26, 2024K241815Protean Fragment Plating System
Skeletal Dynamics, Inc.
HRS
Sep 19, 2024K241709Pectus Blu Support Bar System
Biomet Microfixation
HRS
Sep 17, 2024K241942TriMed Bridge Plates
TriMed, Inc.
HRS
Sep 5, 2024K241356Fine Osteotomy™
Bodycad Laboratories, Inc., CA
HRS
Sep 3, 2024K240487EVOS Patella Plates
Smith & Nephew
HRS
Aug 28, 2024K233816REDEMPTION Charcot Plating System
Vilex, LLC
HRS
Aug 23, 2024K240318SITTER 3.5mm Versatile System
Bonebridge AG, CH
HRS
Aug 19, 2024K241282RibFix Titan™ Fixation System
Riverpoint Medical
HRS
Aug 15, 2024K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Sha
Zimmer Switzerland Manufacturing GmbH, CH
HRS
Aug 13, 2024K241387CoLink NeoFuse MIS Plating System (see attached parts list)
In2bones USA
HRS
Aug 1, 2024K242055Freefix Forearm Plating System
Skeletal Dynamics, Inc.
HRS
Jul 30, 2024K241539Activmotion S
Newclip Technics, FR
HRS
Jul 26, 2024K233994VOLT™ Proximal Humerus 3.5 Plating System
Synthes GmbH, CH
HRS
Jul 23, 2024K241296Gaudi Proximal Humerus Plate
Netbiologics, LLC
HRS
Jul 12, 2024K241018KLS Martin Orthopedic Implants - MR Conditional
KLS-Martin L.P.
HRS
Jun 26, 2024K234059Forma Medical Optimal Plating System
Forma Medical, Inc.
HRS
Jun 26, 2024K232829Versalock Rib and Sternum Plates System
GM Dos Reis Industria e Comercio Ltda., BR
HRS
Jun 20, 2024K240613APTUS Elbow Dorsal Olecranon Plates
Medartis AG, CH
HRS
Jun 11, 2024K230546SIGNEX
Osteonic Co., Ltd., KR
HRS
Jun 5, 2024K241262Baby Gorilla/Gorilla Plating System; Monster Screw System
Paragon 28, Inc.
HRS
May 31, 2024K241218Tyber Medical Anatomical Plating System
Tyber Medical, LLC
HRS
May 24, 2024K233089NeoSpan® Compression Implant System
In2bones USA, LLC
HRS
May 9, 2024K233967DePuy Synthes MatrixSTERNUM Fixation System
Synthes GmbH, CH
HRS
Apr 26, 2024K233873XLO Brand of Locking Distal Humerus Plating System
Ortho Life Systems Private Limited, IN
HRS
Apr 22, 2024K233311Acumed Wrist Plating System
Acumed, LLC
HRS
Apr 19, 2024K232105APTUS Foot System 2.8-3.5
Medartis AG, CH
HRS

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