510(k) Report

Devices descending from K023134

51 later devices reach Jet-X Tin Coated Half Pins 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—
+1K023921Jet-X HA Coated Half PinsSmith & Nephew, Inc.20035027
+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—
+2K210784Extended HA Half PinsSmith & Nephew, Inc.20210—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K050849HA Coated Lag ScrewSmith & Nephew, Inc.200534—
+2K033289Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc.200449—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241539Activmotion SNewclip Technics20240—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—