510(k) Report

Devices descending from K961526

69 later devices reach Press-Fit Porous Shell through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972931Plus Epf Acetabular CupHhl Consulting199768—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K994146Epf-Plus Cementless Press-Fit Acetabular CupPlus Orthopedics200067—
+3K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+3K011719Plus Cancellous Bone ScrewsPlus Orthopedics200163—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+4K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+4K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+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
+5K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+5K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K103352Versafitcup CC TrioMedacta International20114—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+6K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+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—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+6K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+6K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+6K143453Mpact Double Mobility SystemMedacta International20151—
+6K132879Mpact ExtensionMedacta International201411—
+6K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+6K131458Mpact DM Liner ConverterMedacta International20133—
+6K122911Versafitcup CC Trio ExtensionMedacta International20121—
+6K122641Mpact ExtensionMedacta International201214—
+6K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+6K111145Endo HeadMedacta International20110—
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+7K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.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—
+7K211891DM Converter - TiN coatedMedacta International S.A.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—