510(k) Report

Devices descending from K062352

527 later devices reach FRS Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+1K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp2014362
+1K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+1K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+2K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+2K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+2K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+2K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+2K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+2K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+2K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+2K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+2K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+2K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K240487EVOS Patella PlatesSmith & Nephew20240—
+3K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+3K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+3K202326BESPA Charcot SystemBespa Global, LLC20210—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+3K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K193368Smart Correction SystemWishbone Medical, Inc.202031
+3K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K193029Conquest FNSmith & Nephew, Inc.202010—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+3K192592Axis Plating SystemExtremity Medical, LLC20190—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—