510(k) Report

Devices descending from K932755

246 later devices reach Reflection Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K163577Ecofit® Hip SystemImplantcast GmbH201791
+1K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K092098Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc.20101—
+1K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006120—
+1K993082Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentExactech, Inc.19991612
+2K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+2K252451EPORE® XO cup systemImplantcast GmbH20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—
+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—
+2K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K210678implaFit® hip stemsImplantcast GmbH20223—
+2K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—
+2K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.20200—
+2K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+2K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K141797Alteon 6.5MM Bone ScrewsExactech, Inc.20146—
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+2K103352Versafitcup CC TrioMedacta International20114—
+2K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+2K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp.20101—
+2K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+2K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+2K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc.200946—
+2K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc.2007916
+2K070479Exactech Novation Crown Cup and LinersExactech, Inc.20075916
+2K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.20056012
+2K040601Exactech Acumatch a-Series & MCS Constrained Acetabular LinersExactech, Inc.200411
+2K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041451
+2K040613Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc.2004611
+3K252401implaFit® short stemsImplantcast GmbH20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+3K232371Actinia® hip stemsImplantcast GmbH20231—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+3K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+3K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+3K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+3K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc.20184—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+3K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+3K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc.201513—
+3K141960Exactech® Novation® Crown Cup®Exactech, Inc.20150—
+3K143453Mpact Double Mobility SystemMedacta International20151—
+3K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+3K131458Mpact DM Liner ConverterMedacta International20133—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+3K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+3K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+3K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+3K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+3K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+3K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+3K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+3K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.201053—
+3K100269Novation Crown Cup GXL LinersExactech, Inc.201057
+3K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100—
+3K080980Exactech Novation Element Press-Fit Femoral StemsExactech, Inc.2008281
+3K071676Exactech Novation Crown Cup Constrained Liners and RingsExactech, Inc.200702
+3K051335Acumatch 12/14 Press-Fit Femoral StemsExactech, Inc.20050—
+3K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.200464—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+4K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+4K211891DM Converter - TiN coatedMedacta International S.A.20220—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—