510(k) Report

Devices descending from K981201

66 later devices reach Osteolock Acetabular Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993874Bofor Revision CoupPlus Orthopedics200065—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K011719Plus Cancellous Bone ScrewsPlus Orthopedics200163—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+3K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+3K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+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
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+4K103721Mpact Acetabular SystemMedacta International201121—
+4K103352Versafitcup CC TrioMedacta International20114—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K241461Mpact Constrained LinerMedacta International S.A.20251—
+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—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K143453Mpact Double Mobility SystemMedacta International20151—
+5K132879Mpact ExtensionMedacta International201411—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131458Mpact DM Liner ConverterMedacta International20133—
+5K122911Versafitcup CC Trio ExtensionMedacta International20121—
+5K122641Mpact ExtensionMedacta International201214—
+5K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+5K111145Endo HeadMedacta International20110—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+6K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.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—
+6K211891DM Converter - TiN coatedMedacta International S.A.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—