510(k) Report

Devices descending from K953510

48 later devices reach Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+1K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+1K982447Plus Bipolar Prosthesis CocrmoPlus Orthopedics199836—
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K091967Medacta Bipolar HeadMedacta International S.A.20109—
+2K082468Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD…Omni Life Science, Inc.20092123
+2K082705Biopro Bipolar Head, Models 18130-18152Biopro, Inc.20087—
+2K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K191297iNSitu Bipolar Hip SystemTheken Companies, LLC201911
+3K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+3K183114Corin BiPolar-iCorin U.S.A. Limited20193—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+3K132539Ring-Lok Modular Bipolar SystemImplants International, Ltd.20140—
+3K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+3K100761Biopro Polar HeadBiopro, Inc.201041
+3K100151Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM)Omnlife Science20104—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.20250—
+4K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+4K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+4K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—