510(k) Report

Devices descending from K082468

21 later devices reach Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM]… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+1K183114Corin BiPolar-iCorin U.S.A. Limited20193—
+1K171156OMNI Anseris Hip StemOmnilife Science20170—
+1K100761Biopro Polar HeadBiopro, Inc.201041
+1K100151Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM)Omnlife Science20104—
+1K091967Medacta Bipolar HeadMedacta International S.A.20109—
+2K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.20250—
+2K241461Mpact Constrained LinerMedacta International S.A.20251—
+2K241472Icona Hip StemCorin U.S.A. Limited20241—
+2K191297iNSitu Bipolar Hip SystemTheken Companies, LLC201911
+2K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+2K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+2K132539Ring-Lok Modular Bipolar SystemImplants International, Ltd.20140—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K261576Icona Hip StemCorin, Ltd.20260—
+3K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+3K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—