510(k) Report

Devices descending from K960658

45 later devices reach Collarless Polished Taper Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191735CPT Hip SystemZimmer, Inc.20202—
+1K130610Sirius Femoral StemBiomet, Inc.2013102
+1K030265CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00Zimmer, Inc.2003103
+1K983136Depuy Luster StemDePuy Orthopaedics, Inc.1998010
+1K982918Depuy C-Stem SystemDePuy Orthopaedics, Inc.199825—
+2K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228—
+2K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K152530UCP StemUnited Orthopedic Corporation20162—
+2K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+2K142295Sirius Femoral Stem, Size 30ABiomet, Inc.20149—
+2K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc.200632
+2K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.200423—
+2K013350Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc.200114—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+3K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+3K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20202—
+3K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+3K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+3K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc.200814—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—