510(k) Report

Devices descending from K093235

65 later devices reach Ringloc + Hybrid Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+1K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+1K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—
+2K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+2K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+2K190057DJO Acetabular SystemEncore Medical L.P.201925
+2K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+2K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+2K183582MPACT ExtensionMedacta International S.A.20194—
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+2K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+2K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+2K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+2K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+2K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+2K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+3K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+3K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K182099Delta TT ProLima Corporate S.P.A.20183—
+3K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+3K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+4K261453G7® Acetabular SystemZimmer Biomet20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—