510(k) Report

Devices descending from K921277

139 later devices reach Ranawat/Burstein Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050124Porous Coated Acetabular ComponentsBiomet, Inc.20051381
+2K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc.200713719
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+3K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+3K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc.20106530
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+4K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+4K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+4K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+4K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+4K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+4K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+5K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K190057DJO Acetabular SystemEncore Medical L.P.201925
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+5K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+5K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+5K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+5K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+5K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+5K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+6K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+6K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+6K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+7K261453G7® Acetabular SystemZimmer Biomet20260—
+7K253630Mpact 3D Metal FoamMedacta International S.A.20260—