510(k) Report

Devices descending from K122158

21 later devices reach PBP Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+2K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+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—
+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—
+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—