510(k) Report

Devices descending from K072020

95 later devices reach Restoration Adm System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+1K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+1K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+1K112556Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 InsertsHowmedica Osteonics Corp.2011101
+1K111572Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Serf2011275
+1K103233Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp.2011521
+1K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+1K083116Versafit Cup Double Mobility SystemMedacta International S.A.2009592
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+2K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+2K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+2K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+2K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+2K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K200854DePuy PINNACLE Dual Mobility LinerDepuy Ireland UC20207—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+2K191831MobiliT CupCorin U.S.A. Limited20203—
+2K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K181744BI-MENTUM dual mobility systemSerf201810—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K143453Mpact Double Mobility SystemMedacta International20151—
+2K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+2K131458Mpact DM Liner ConverterMedacta International20133—
+2K110135Polarcup Dual Mobility SystemSmith & Nephew, Inc.201114—
+2K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+2K103721Mpact Acetabular SystemMedacta International201121—
+2K103352Versafitcup CC TrioMedacta International20114—
+2K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K231522EMPHASYS™ Dual Mobility SystemDepuy Ireland UC20240—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—
+3K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+3K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K200391MPACT ExtensionMedacta International S.A.20210—
+3K203532BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC20216—
+3K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K171934Birmingham Hip (BH) Dual Mobility InsertSmith & Nephew, Inc.20179—
+3K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K132879Mpact ExtensionMedacta International201411—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K122641Mpact ExtensionMedacta International201214—
+3K122244Polarcup Dual Mobility SystemSmith & Nephew, Inc.20125—
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+3K111145Endo HeadMedacta International20110—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—