510(k) Report

Devices descending from K880282

135 later devices reach Lima-Lto. Sem Modular External Stablizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K122641Mpact ExtensionMedacta International201214—
+5K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+5K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+5K111145Endo HeadMedacta International20110—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+6K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+6K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+6K190847REDAPT Blade AugmentsSmith & Nephew, Inc.20190—
+6K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+6K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+6K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K252451EPORE® XO cup systemImplantcast GmbH20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+7K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+7K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K203420EcoFit® Hip SystemImplantcast GmbH20214—
+7K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+7K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+7K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+9K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+9K243162World LinerSignature Orthopaedics Pty, Ltd.20240—