510(k) Report

Devices descending from K161184

19 later devices reach iNSitu Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+1K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+1K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+1K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+1K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+1K163577Ecofit® Hip SystemImplantcast GmbH201791
+1K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+2K252451EPORE® XO cup systemImplantcast GmbH20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+2K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K210678implaFit® hip stemsImplantcast GmbH20223—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K252401implaFit® short stemsImplantcast GmbH20260—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+3K232371Actinia® hip stemsImplantcast GmbH20231—