510(k) Report

Devices descending from K931641

173 later devices reach Porocoat Porous Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+7K221104Actera™ hip systemConformis, Inc.202211
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+7K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+7K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+7K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+7K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+7K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+7K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+7K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+7K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc.201236—
+8K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+8K261576Icona Hip StemCorin, Ltd.20260—
+8K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+8K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+8K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+8K243809Biolox® Delta Revision headsLimacorporate20250—
+8K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+8K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+8K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+8K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+8K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+8K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+8K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+8K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+8K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+8K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+8K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+8K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+8K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+8K182099Delta TT ProLima Corporate S.P.A.20183—
+8K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+8K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+8K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+8K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+8K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+8K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+8K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+9K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+9K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+9K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+9K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+9K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+9K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+9K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+9K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+9K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+9K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+9K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+9K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+9K170473C2 femoral stemLima Corporate S.P.A.20170—
+9K160011H-Max S stemLima Corporate S.P.A.20161—
+10K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+10K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+10K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+10K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+10K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+11K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—