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
Oct 23, 2026K263407Tempo Plating System
Pace Surgical
HRS
Oct 23, 2026K262779ANTHEM™ Fracture System
Globus Medical, Inc.
HRS
Oct 15, 2026K263269Park's Pectus System
Tdm Co., Ltd., KR
HRS
Oct 2, 2026K261611TDM Large Bone Plate and Screw System
Tdm Co., Ltd., KR
HRS
Sep 28, 2026K262649Alians Forearm
Newclip Technics, FR
HRS
Sep 23, 2026K261892ProRib Fixation System
Costa Surgical, Inc.
HRS
Sep 18, 2026K262098EnHAnce PEEK Bunion System
Nvision Biomedical Technologies
HRS
Sep 15, 2026K262963TMC Implant Fixation System
Treace Medical Concepts, Inc.
HRS
Sep 3, 2026K261647Tempo Plating System; Ultra Compression Screw System
Pace Surgical
HRS
Aug 28, 2026K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate Sys
Ortler Global Tibbi Gerecler Anonim Sirketi, TR
HRS
Aug 19, 2026K262537Versalock Sterile Plating System
GM Dos Reis Industria e Comercio Ltda., BR
HRS
Aug 13, 2026K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
Mikron Makina San. ve Tic. Ltd. Sti., TR
HRS
Jul 28, 2026K261511Xpert Ankle
Newclip Technics, FR
HRS
Jul 21, 2026K261406Versalock Proximal Tibial Plating System
GM Dos Reis Industria e Comercio Ltda., BR
HRS
Jul 16, 2026K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spannin
TriMed, Inc.
HRS
Jul 8, 2026K261191Alians Elbow S
Newclip Technics, FR
HRS
Jul 1, 2026K261054RibPlate System
Stryker Leibinger GmbH & Co KG, DE
HRS
Jun 26, 2026K261351SALGINA 2.5mm Distal Radius System
Bonebridge AG, CH
HRS
Jun 16, 2026K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Pla
I.T.S. GmbH, AT
HRS
Jun 12, 2026K261207Exalta Proximal Tibia Plating System
Tyber Medical, LLC
HRS
Jun 5, 2026K260761APTUS Clavicle System 2.8
Medartis AG, CH
HRS
Jun 2, 2026K261002Pectus Blu System
Biomet Microfixation
HRS
May 29, 2026K261038Xpert PFP
Newclip Technics, FR
HRS
May 9, 2026K261145Avanti Distal Elbow ORIF System
Avanti Orthopaedics, LLC
HRS
Apr 30, 2026K260323OrthoPediatrics® Locking Cannulated Blade Plate System
OrthoPediatrics Corp.
HRS
Apr 24, 2026K260411PC Fix System
Chest Wall Innovations, Inc.
HRS
Apr 24, 2026K260228POYA 3.5mm Medial Proximal Tibia System
Bonebridge AG, CH
HRS
Apr 24, 2026K260054I.T.S. PRS Phoenix II
I.T.S. GmbH, AT
HRS
Apr 10, 2026K260090SMART Osteotomy System
Actis Medical Pty., Ltd., AU
HRS
Apr 1, 2026K253718enHAnce PEEK Bunion System
Nvision Biomedical Technologies, Inc.
HRS
Mar 25, 2026K260291Vortex5 Tailor's Bunion Correction System
Nvision Biomedical Technologies, Inc.
HRS
Mar 25, 2026K260274Airlock® Ankle Plating System
Novastep SAS, FR
HRS
Mar 24, 2026K254253LOQTEQ® VA Proximal Humerus Plate 3.5
Aap Implantate AG, DE
HRS
Mar 23, 2026K254288Clavicle Fixation System
Skeletal Dynamics, Inc.
HRS
Mar 19, 2026K260448CastleLoc Pectus Bar System
L&K BIOMED Co., Ltd., KR
HRS
Mar 17, 2026K260390Super Upper Limbs Versalock Plating System
GM Dos Reis Industria e Comercio Ltda., BR
HRS
Mar 17, 2026K254053APS Spear Locking Plate
A Plus Biotechnology Co., Ltd., TW
HRS
Mar 16, 2026K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5
Medartis AG, CH
HRS
Mar 11, 2026K253906Xpert Hand
Newclip Technics, FR
HRS
Mar 10, 2026K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System
Synthes GmbH, CH
HRS
Mar 9, 2026K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
Synthes GmbH, CH
HRS
Mar 3, 2026K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
Arthrex, Inc.
HRS
Mar 2, 2026K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System
Synthes GmbH, CH
HRS
Feb 27, 2026K254249HKT Anatomical Locking Trauma System
Hankil Tech Medical Co., Ltd., KR
HRS
Feb 26, 2026K252166RIB LINK™ Fixation System
Globus Medical, Inc.
HRS
Feb 20, 2026K254162KLS Martin Ixos System
KLS Martin L.P.
HRS
Feb 20, 2026K253660KLS Martin Pure Pectus System
KLS-Martin L.P.
HRS
Feb 12, 2026K251732Wrist Fracture System
Met One Technologies, LLC
HRS
Jan 21, 2026K253713Arthrex Variable Angle (VA) Proximal Tibia Plating System
Arthrex, Inc.
HRS
Jan 15, 2026K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL
TriMed, Inc.
HRS

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