510(k) Report

Devices descending from K030205

34 later devices reach Consensus Unipolar Head, Cocr through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+1K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+2K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+2K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+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—
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+3K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+4K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+4K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+4K171156OMNI Anseris Hip StemOmnilife Science20170—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K232371Actinia® hip stemsImplantcast GmbH20231—