510(k) Report

Devices descending from K090982

24 later devices reach Smith & Nephew Hip Systems with HA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.20200—
+1K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+2K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K232371Actinia® hip stemsImplantcast GmbH20231—