510(k) Report

Devices descending from K002996

203 later devices reach Synergy HA Coated Porous Femoral Stems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K090982Smith & Nephew Hip Systems with HASmith & Nephew, Inc.201024—
+1K061066Synergy Hip SystemSmith & Nephew, Inc.200616—
+1K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+1K052426Smith & Nephew Modular HipSmith & Nephew, Inc.20056—
+1K042252Nexflex Total Hip SystemAlphatec/Nexmed20040—
+1K042127Smith & Nephew Modular HipSmith & Nephew, Inc.200417—
+1K032683Genesis II Porous Plus HA Knee SystemSmith & Nephew, Inc.200319—
+1K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003146—
+1K023302Echelon Porous Plus HA Hip StemsSmith & Nephew, Inc.200225—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.20200—
+2K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd.20195—
+2K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+2K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+2K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+2K100897Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc.201012—
+2K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+2K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041451
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Signature Orthopaedics Pty, Ltd.20224—
+3K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+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—
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+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—
+4K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+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—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+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—
+5K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+5K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.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—
+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