510(k) Report

Devices descending from K022549

54 later devices reach Restoration Modular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+1K213129Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20218—
+1K193233Restoration® Modular Hip SystemHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)20200—
+1K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+1K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.20061—
+1K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc.200324—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+2K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+2K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+2K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc.20120—
+2K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+2K113556Wagner Cone Prosthesis SystemZimmer GmbH201291
+2K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp20107—
+2K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K212327M-Vizion MonoblocMedacta International S.A.20221—
+3K220405Amis K LongMedacta International S.A.20220—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K190100USTAR II SystemUnited Orthopedic Corporation201925
+3K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH20191—
+3K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+3K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+3K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH20168—
+3K151739Revision Femoral StemLima Corporate S.P.A.20157—
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+3K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+3K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+4K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+4K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+4K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+4K161226Revision Femoral StemLima Corporate S.P.A.20170—
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—