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
Apr 17, 2024K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate),
TriMed, Inc.
HRS
Apr 12, 2024K240703Fine Osteotomy™
Bodycad Laboratories, Inc., CA
HRS
Apr 5, 2024K232115TDM Large Bone Plate and Screw System
Tdm Co., Ltd., KR
HRS
Mar 25, 2024K233919VariAx 2 Distal Radius System
Stryker GmbH, CH
HRS
Mar 21, 2024K234062APTUS Hand Scaphoid Plates
Medartis AG, CH
HRS
Mar 21, 2024K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
DePuy Synthes
HRS
Feb 22, 2024K240173Treace Medical Systems (TMC) Plating System
Treace Medical Concepts, Inc.
HRS
Jan 19, 2024K231213HKT Anatomical Locking Trauma System
Hankil Tech Medical Co., Ltd., KR
HRS
Jan 18, 2024K234031Medline UNITE Ancillary Foot Recon Plating System
Medline Industires, LP
HRS
Jan 12, 2024K231684Quick - Radius Disposable Set
GM Dos Reis Industria e Comercio Ltda., BR
HRS
Dec 21, 2023K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System
Tyber Medical, LLC
HRS
Dec 21, 2023K233154SkyOPS™ Orthopedic Plate System
Sky Surgical, LLC
HRS
Dec 20, 2023K233017TM Plating System
Tyber Medical, LLC
HRS
Dec 15, 2023K232394Internal Locking Plate and Screw Fixation System
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd., CN
HRS
Dec 14, 2023K231887ARIX Ankle Distal Tibia System
Jeil Medical Corporation, KR
HRS
Dec 13, 2023K232652Anatomical Plating System (various)
Tyber Medical, LLC
HRS
Dec 8, 2023K232515Valkyrie Thoracic Fixation System
Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices
HRS
Dec 4, 2023K232693Tyber Medical Distal Radius Plating System
Tyber Medical, LLC
HRS
Sep 29, 2023K230591TriLEAP Plating System
Crossroads Extremity Systems
HRS
Sep 25, 2023K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
Exactech, Inc.
HRS
Sep 1, 2023K230805TriMed Clavicle Fixation System
TriMed, Inc.
HRS
Sep 1, 2023K230623KITE Distal Fibula Kit
Intrauma S.P.A, IT
HRS
Aug 28, 2023K231623Distal Elbow Plating System
Skeletal Dynamics, Inc.
HRS
Aug 24, 2023K223150APS Metal Plate & Screw System
A Plus Biotechnology Co., Ltd., TW
HRS
Aug 18, 2023K232144Sterile Products of the APTUS System
Medartis AG, CH
HRS
Aug 18, 2023K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
Stryker GmbH
HRS
Aug 18, 2023K231257Pangea Utility Plating System, Pangea Platform
Stryker GmbH
HRS
Aug 17, 2023K230690Tandry Locking Plate System
Microware Precision Co., Ltd., TW
HRS
Jul 19, 2023K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System
Bonebridge AG, CH
HRS
Jul 17, 2023K231441ARIX Ankle System
Jeil Medical Corporation, KR
HRS
Jun 2, 2023K230971APTUS® 3.5 TriLock Straight Plates
Medartis AG, CH
HRS
May 30, 2023K223762Smith & Nephew ACCORD™ Cable System
Smith & Nephew
HRS
May 25, 2023K222624KLS Martin LINOS Wrist System
KLS-Martin L.P.
HRS
May 3, 2023K230938ARIX Humerus System
Jeil Medical Corporation, KR
HRS
Apr 27, 2023K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
Stryker GmbH
HRS
Apr 25, 2023K230204ALPHALOK Plating System
Vilex, LLC
HRS
Apr 7, 2023K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)
Stryker GmbH
HRS
Mar 30, 2023K223853Medartis APTUS® Ulna Plates
Medartis AG, CH
HRS
Mar 30, 2023K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
Crossroads Extremity Systems, LLC
HRS
Mar 29, 2023K230527WishBone Medical Plate and Screw System
Wishbone Medical, Inc.
HRS
Mar 29, 2023K222397KLS Martin Level One Rib Fixation System
KLS-Martin L.P.
HRS
Mar 28, 2023K221938KLS Martin Pure Pectus System
KLS Martin L.P.
HRS
Mar 17, 2023K230141LOQTEQ® VA Elbow Plates 2.7/3.5 System
Aap Implantate AG, DE
HRS
Mar 7, 2023K222465Tyber Medical Anatomical Plating System
Tyber Medical, LLC
HRS
Jan 27, 2023K213059Tibia and Fibula System
Auxein Medical Private Limited, IN
HRS
Jan 25, 2023K222665Medline UNITE® Ankle Fusion Plating System
Medline Industries, Inc.
HRS
Jan 25, 2023K221150Advanced Bone Plate
Double Medical Technology, Inc., CN
HRS
Jan 21, 2023K223118OIC Variable Angle Small Fragment Locking Plate System
Orthopaedic Implant Company
HRS
Jan 18, 2023K221088Anatomic Bone Plate
Double Medical Technology, Inc., CN
HRS
Jan 5, 2023K221181Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc.
HRS

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