510(k) Report

Devices descending from K001660

48 later devices reach Mallory Head Modular Calcar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048—
+1K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.20033916
+2K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+2K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+2K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc.200538—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+3K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+3K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+3K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp20107—
+3K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+4K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K220405Amis K LongMedacta International S.A.20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K190100USTAR II SystemUnited Orthopedic Corporation201925
+4K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+4K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+4K151739Revision Femoral StemLima Corporate S.P.A.20157—
+4K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+4K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+5K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+5K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+5K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+5K161226Revision Femoral StemLima Corporate S.P.A.20170—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—
+6K212327M-Vizion MonoblocMedacta International S.A.20221—
+6K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—