510(k) Report

Devices descending from K953397

57 later devices reach Hex-Fix Field Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+1K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+1K090926Smith & Nephew Rail SystemSmith & Nephew, Inc.200910—
+1K023134Jet-X Tin Coated Half PinsSmith & Nephew, Inc.200251—
+1K970751Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div.199711—
+2K253291Excelsior SystemBlue Ocean Global20260—
+2K253202Hoffmann LRF SystemStryker GmbH20250—
+2K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+2K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+2K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+2K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd.20202—
+2K023921Jet-X HA Coated Half PinsSmith & Nephew, Inc.20035027
+3K241357XT3 SystemBiodynamik, Inc.20251—
+3K210784Extended HA Half PinsSmith & Nephew, Inc.20210—
+3K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+3K050849HA Coated Lag ScrewSmith & Nephew, Inc.200534—
+3K033289Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc.200449—
+4K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+4K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+6K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+7K173746Activmotion RangeNewclip Technics20181—
+7K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+8K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+8K241539Activmotion SNewclip Technics20240—
+8K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+9K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+10K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+10K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—