510(k) Report

Devices descending from K944565

522 later devices reach KLS-Martin Micro Osteosythesis System (1.5MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+5K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+5K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+5K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+5K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K181806ARIX Sternal SystemJeil Medical Corporation20180—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K173579Thorecon™ Fixation SystemA & E Medical Corporation20181—
+5K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+5K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+5K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+5K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+5K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544—
+5K142581APTUS Foot SystemMedartis AG201522—
+5K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+5K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+5K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K140376Variax 2 SystemStryker Trauma AG201423—
+5K133858Tensyn BandDallen Medical, Inc.20143—
+5K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2014451
+5K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+5K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+5K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246—
+5K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275—
+5K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+5K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+5K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+5K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+5K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+5K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+5K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+5K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+5K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+5K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+5K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K253906Xpert HandNewclip Technics20260—
+6K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+6K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+6K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242988Genostis Osteosynthesis SystemGenostis AF20250—
+6K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+6K243469SignexOsteonic Co., Ltd.20250—
+6K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+6K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+6K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+6K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+6K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—