510(k) Report

Devices descending from K010367

31 later devices reach Modification to Titanium Tri-Lock Hips Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+1K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+1K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+1K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+1K121563Corin Trifit TS HipCorin USA2012101
+2K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+2K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+2K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K211866Bencox THR SystemCorentec Co., Ltd.20210—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+2K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+2K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+2K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+2K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+2K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+2K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+2K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+2K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+2K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—