510(k) Report

Devices descending from K051986

75 later devices reach Synthes 4.5 MM LCP Straight Reconstruction Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+1K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+1K072250Supercable Grip and Plate SystemKinamed, Inc.200711
+1K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+1K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K261038Xpert PFPNewclip Technics20260—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+2K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+2K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+2K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150626Rush Medullary PinsZimmer, Inc.20150—
+3K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+5K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—