510(k) Report

Devices descending from K102399

33 later devices reach Consensus Taperset Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+1K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+1K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+1K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+1K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+1K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+1K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+2K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+2K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+2K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+2K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+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—
+3K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+3K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+3K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K171156OMNI Anseris Hip StemOmnilife Science20170—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K232371Actinia® hip stemsImplantcast GmbH20231—