510(k) Report

Devices descending from K031693

39 later devices reach Mallory/Head Modular Calcar with and Without HA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+1K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc.200538—
+2K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+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—
+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
+3K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+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
+3K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+3K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+3K151739Revision Femoral StemLima Corporate S.P.A.20157—
+3K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+3K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+4K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+4K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+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—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K212327M-Vizion MonoblocMedacta International S.A.20221—
+5K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—