510(k) Report

Devices descending from K063487

257 later devices reach Merete BLP Small Fragment Locking Bone Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102688Merete Locking Bone Plate System IIMerete Medical GmbH20100—
+1K090063Merete Locking Bone Plate SystemMerete Medical, Inc.2009241—
+1K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008256—
+2K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+2K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+2K100721Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd.201013—
+2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K162380Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd.20170—
+3K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K151508IRENE Locking Compression Plate SystemTianjin Zhengtian Medical Instrument Co., Ltd.20160—
+3K142581APTUS Foot SystemMedartis AG201522—
+3K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+3K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K140376Variax 2 SystemStryker Trauma AG201423—
+3K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+3K132642Locking Plate SystemBeijing Libeier Bio-Engineering Institute Co., Ltd.20130—
+3K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd.20137—
+3K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+3K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+3K112798Locking Compression Plate SystemShanghai Microport Orthopedics Co., Ltd.20120—
+3K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253906Xpert HandNewclip Technics20260—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+4K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242988Genostis Osteosynthesis SystemGenostis AF20250—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+4K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K211435PAO Cortical ScrewMedacta International S.A.20210—
+4K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+4K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+4K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K191636APTUS Foot SystemMedartis AG20190—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+4K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—