510(k) Report

Devices descending from K001745

36 later devices reach Modification to Provident Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190276Provident II Hip StemStelkast, Inc.20192—
+1K122773Cross-Over Acetabular Shell & LinerStelkast Company201261
+1K073068Accin Hip SystemAccelerated Innovation, LLC200828—
+2K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+2K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+2K201733Provident II Hip StemsGlobus Medical, Inc.20210—
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100—
+2K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp.20101—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K232371Actinia® hip stemsImplantcast GmbH20231—