510(k) Report

Devices descending from K100776

228 later devices reach Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+1K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+1K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+1K200062Foot and Ankle SystemLeith Medical, LLC20210—
+1K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+1K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+1K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+1K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+1K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K142581APTUS Foot SystemMedartis AG201522—
+1K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+1K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+1K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+1K140376Variax 2 SystemStryker Trauma AG201423—
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+1K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+1K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+1K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+1K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+1K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+1K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+2K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K253906Xpert HandNewclip Technics20260—
+2K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+2K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+2K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+2K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+2K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+2K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+2K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+2K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+2K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+2K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+2K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+2K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+2K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+2K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K191636APTUS Foot SystemMedartis AG20190—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+2K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+2K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+2K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+2K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+2K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+2K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+2K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+2K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+2K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+2K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K143061Activ Ankle Locking Plating SystemNewclip Technics20158—