510(k) Report

Devices descending from K994146

67 later devices reach Epf-Plus Cementless Press-Fit Acetabular Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K011719Plus Cancellous Bone ScrewsPlus Orthopedics200163—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+2K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+2K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+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
+3K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+3K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K103352Versafitcup CC TrioMedacta International20114—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+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—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K111145Endo HeadMedacta International20110—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.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—
+5K211891DM Converter - TiN coatedMedacta International S.A.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—