510(k) Report

Devices descending from K935484

95 later devices reach Provident Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201733Provident II Hip StemsGlobus Medical, Inc.20210—
+1K190276Provident II Hip StemStelkast, Inc.20192—
+1K132158Novohip Total Hip SystemNovosource, Inc.201461
+1K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company201179—
+1K073068Accin Hip SystemAccelerated Innovation, LLC200828—
+2K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+2K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+2K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+2K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+2K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+2K122773Cross-Over Acetabular Shell & LinerStelkast Company201261
+2K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+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—
+3K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+3K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+3K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+3K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+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—
+3K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K192198Conformis Hip SystemConformis, Inc.2019121
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+7K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—