510(k) Report

Devices descending from K092386

46 later devices reach R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+1K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.20200—
+1K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc.20184—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+1K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+1K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+1K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+1K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+2K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+2K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+2K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+2K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+2K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+2K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+2K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+2K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+2K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+2K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+2K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K232371Actinia® hip stemsImplantcast GmbH20231—