510(k) Report

Devices descending from K011262

547 later devices reach Modification to the Bold Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+1K070617Cannulated ScrewFournitures Hospitalieres Industrie20074—
+1K062352FRS ScrewDePuy Orthopaedics, Inc.2006527—
+1K050346Stabilization ScrewNew Deal, S.A.2005554
+2K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+2K160617Large Screws RangeNewclip Technics20166—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+2K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+2K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+2K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp2014362
+2K131920Stabilization ScrewIn2bones Sas2014183
+2K130954Ars Screw; Slant ScrewAdvanced Interventional Technology, LLC20130—
+2K091798Merete Compression ScrewsMerete Medical GmbH200926—
+2K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K071639Qwix Positioning ScrewNewdeal Sas2007521
+3K254280F.A.S.T ScrewSteps Ortho20260—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K172596Large Screws RangeNewclip Technics20174—
+3K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+3K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+3K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+3K124027Monster Screw SystemApogee Orthosolutions201341—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+3K102528N-Force Fixation SystemInnovision, Inc.20115—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+3K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+3K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+3K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+4K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—