510(k) Report

Devices descending from K070756

91 later devices reach Smith and Nephew Reflection 3 Acetabular System 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—
+1K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+1K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.20200—
+1K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc.201513—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+1K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+1K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+1K103721Mpact Acetabular SystemMedacta International201121—
+1K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+1K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+1K092098Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc.20101—
+1K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc.200946—
+2K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+2K250450Coated hip implantsMedacta International S.A.20250—
+2K241461Mpact Constrained LinerMedacta International S.A.20251—
+2K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K230011Mpact ExtensionMedacta International S.A.20233—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+2K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+2K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+2K200391MPACT ExtensionMedacta International S.A.20210—
+2K183582MPACT ExtensionMedacta International S.A.20194—
+2K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+2K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc.20184—
+2K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+2K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc.20175—
+2K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+2K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+2K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+2K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc.20164—
+2K143453Mpact Double Mobility SystemMedacta International20151—
+2K132879Mpact ExtensionMedacta International201411—
+2K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K131458Mpact DM Liner ConverterMedacta International20133—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+2K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+2K122911Versafitcup CC Trio ExtensionMedacta International20121—
+2K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+2K122641Mpact ExtensionMedacta International201214—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+2K111145Endo HeadMedacta International20110—
+2K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+3K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+3K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K190847REDAPT Blade AugmentsSmith & Nephew, Inc.20190—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+4K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K232371Actinia® hip stemsImplantcast GmbH20231—