510(k) Report

Devices descending from K981372

710 later devices reach Synthes 3.0 MM PC-Fix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+4K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+4K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC20173—
+4K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+4K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+4K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+4K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+4K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+4K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+4K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+4K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+4K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+4K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+4K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140607Aap Loqtec (R) Olecranon PlateAap Implantate AG20141—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141—
+4K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+4K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+4K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+4K1334371ST MTP PlateOsteomed20132—
+4K131834Wolf Long Bone Plate SystemToby Orthopaedics20130—
+4K131636Polarus ConnectAcumed, LLC20130—
+4K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+4K131764Acumed Wrist Spanning PlateAcumed, LLC20137—
+4K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+4K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+4K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+4K124027Monster Screw SystemApogee Orthosolutions201341—
+4K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+4K130009Variax 2 Compression Plating SystemStryker Trauma AG2013271
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc.20135—
+4K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+4K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+4K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+4K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+4K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+4K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+4K113718NCB Straight Narrow Shaft PlatesZimmer GmbH201271
+4K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+4K112926Axsos Locking Plate SystemStryker Corp.20110—
+4K112406Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc.20113—
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+4K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+4K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+4K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+4K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+4K102688Merete Locking Bone Plate System IIMerete Medical GmbH20100—
+4K100721Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd.201013—
+4K100944Clavicle Locking Plate SystemNewclip Technics20109—
+4K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+4K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+4K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+4K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.2010182
+4K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+4K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Synthes (Usa)200951—
+4K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+4K090063Merete Locking Bone Plate SystemMerete Medical, Inc.2009241—
+4K060041Trimed Bone PlatesTriMed, Inc.2006263
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+5K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC202511
+5K250155Xpert KneeNewclip Technics20250—