510(k) Report

Devices descending from K033289

49 later devices reach Modification to Jet-X HA Coated Half Pins through their predicates, nearest generation first.

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