510(k) Report

Devices descending from K060635

69 later devices reach Consensus Acetabular Shell System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+1K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc.201421—
+1K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+1K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+1K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+1K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+2K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+2K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+2K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+2K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+2K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+2K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+2K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+2K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+3K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+3K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+3K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K202484Cordera Hip SystemConformis, Inc.202022
+3K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+3K192198Conformis Hip SystemConformis, Inc.2019121
+3K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+3K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+3K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K231178ACTERA™ hip systemConformis, Inc.20230—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+4K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+4K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+6K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—