510(k) Report

Devices descending from K022556

30 later devices reach Reflection Modified Acetabular Shells through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K163577Ecofit® Hip SystemImplantcast GmbH201791
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K090982Smith & Nephew Hip Systems with HASmith & Nephew, Inc.201024—
+2K252451EPORE® XO cup systemImplantcast GmbH20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K210678implaFit® hip stemsImplantcast GmbH20223—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—
+2K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.20200—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+3K252401implaFit® short stemsImplantcast GmbH20260—
+3K232371Actinia® hip stemsImplantcast GmbH20231—
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+8K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+8K243162World LinerSignature Orthopaedics Pty, Ltd.20240—