510(k) Report

Devices descending from K991485

182 later devices reach Synergy Porous Size 8 Hip Stem 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
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+1K061066Synergy Hip SystemSmith & Nephew, Inc.200616—
+1K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+1K052426Smith & Nephew Modular HipSmith & Nephew, Inc.20056—
+1K042127Smith & Nephew Modular HipSmith & Nephew, Inc.200417—
+1K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003146—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+2K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+2K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+2K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+2K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+2K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041451
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+3K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+3K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+3K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+3K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+3K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp.20101—
+3K080980Exactech Novation Element Press-Fit Femoral StemsExactech, Inc.2008281
+3K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.20056012
+3K051335Acumatch 12/14 Press-Fit Femoral StemsExactech, Inc.20050—
+3K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.200464—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc.20165—
+4K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+4K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K113320Novation Element Femoral Stem, 12/14 Collarless Standard/High Offset HA Coated…Exactech, Inc.20120—
+4K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc.201054—
+4K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100—
+4K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.20090—
+4K070479Exactech Novation Crown Cup and LinersExactech, Inc.20075916
+4K063279Novation Splined RDD Femoral StemsExactech, Inc.200602
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—
+5K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+5K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+5K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K162732Exactech® Alteon® HA Femoral StemExactech, Inc.201711
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+5K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+5K141960Exactech® Novation® Crown Cup®Exactech, Inc.20150—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.201053—
+5K100269Novation Crown Cup GXL LinersExactech, Inc.201057
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—