510(k) Report

Devices descending from K011335

840 later devices reach Synths One-Third Tubular DCL Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262649Alians ForearmNewclip Technics20260—
+1K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K243469SignexOsteonic Co., Ltd.20250—
+1K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+1K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+1K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+1K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+1K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System…Bonebridge AG20219—
+1K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011—
+1K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K182466AOS Calcaneal Plating SystemAdvanced Orthopaedic Solutions20180—
+1K181587ORTHOLOC SPS Shoulder Plating SystemTornier, Inc.20181—
+1K181035AOS Small Fragment Plating System LiteAdvanced Orthopaedic Solutions, Inc. (Aos)20181—
+1K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+1K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+1K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+1K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+1K143394Acumed Small Fragment Base SetAcumed, LLC201518—
+1K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+1K141204Variax 2 One Third Tubular Plating SystemStryker Trauma AG20147—
+1K133536Emerge Medical Bone Plate SystemEmerge Medical20140—
+1K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+1K131834Wolf Long Bone Plate SystemToby Orthopaedics20130—
+1K131480Emerge Medical Locking One-Third Tubular Plate SystemEmerge Medical20130—
+1K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+1K122936Ankle Trauma SystemOrthopro, LLC20131—
+1K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+1K113652Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq…Aap Implantate AG20128—
+1K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+1K112437Arthrex Fracture SystemArthrex, Inc.201191—
+1K102785Trimed Radiocarpal Fusion SystemTriMed, Inc.20112—
+1K102282The Varia Fibula Locked Plating System Line Extension Addition of Straight PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201077—
+1K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp)20103—
+1K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+1K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+1K051083Acumed Scapula Congruent Bone Plate SystemAcumed, LLC20052—
+1K012655Congruent Bone Plate SystemAcu Med, Inc.200179216
+2K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K261191Alians Elbow SNewclip Technics20260—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+2K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+2K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+2K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+2K243275Equinoxe® Scapula Fracture SystemExactech, Inc.20250—
+2K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+2K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+2K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K230546SignexOsteonic Co., Ltd.20242—
+2K233311Acumed Wrist Plating SystemAcumed, LLC20243—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+2K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+2K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+2K202803Activmotion S DTONewclip Technics20210—
+2K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+2K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+2K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+2K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+2K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K201149CoLink Plating SystemIn2bones USA, LLC20200—
+2K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+2K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+2K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+2K191711ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc.20190—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K180972ARIX Clavicle SystemJeil Medical Corporation20181—