510(k) Report

Devices descending from K101072

22 later devices reach Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+2K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+3K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+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—
+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—