510(k) Report

Devices descending from K093846

144 later devices reach Longevity IT Highly Crosslinked Polyethylene Elevated Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+1K151448Continuum and Trilogy Integrated Taper (IT) Acetabular SystemsZimmer, Inc.20156—
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+1K123019Longevity IT Highly Crosslinked Polyethyene LinersZimmer, Inc.20120—
+1K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+1K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Zimmer, Inc.2010143—
+2K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+2K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—
+2K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+2K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+2K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+2K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc.2011137—
+3K261453G7® Acetabular SystemZimmer Biomet20260—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+3K161592Persona Partial Knee SystemBiomet, Inc.201652
+3K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+3K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+3K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+4K251834Persona Partial KneeZimmer Biomet20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+4K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+4K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+4K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+4K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+5K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+5K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K230011Mpact ExtensionMedacta International S.A.20233—