510(k) Report

Devices descending from K031462

128 later devices reach The Nexgen Knee System Uncemented Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+1K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+1K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular200674—
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460—
+2K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+2K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+2K210554Physica systemLima Corporate S.P.A.20212—
+2K200653AMF Revision TT ConesLima Corporate S.P.A.20203—
+2K182085Balanced Knee Revision System Trabecular Tibial Cone AugmentsOrtho Development Corporation20180—
+2K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+2K162775Legion Cone SystemSmith & Nephew, Inc.201752
+2K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics2015401
+2K142933Biomet Tibial traysBiomet, Inc.201463
+2K120990Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK…Zimmer Trabecular Metal Technology201271
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+2K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+2K103517Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc.201111—
+2K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+2K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.201053—
+2K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+2K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp20074—
+2K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+2K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp200647—
+2K041872Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral PegsBiomet Manufacturing Corp20040—
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+3K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+3K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+3K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+3K240324EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis)20241—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K233507EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.20240—
+3K234011AMF TT ConesLima Corporate S.P.A.20240—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K212746ATTUNE Revision ConesDepuy Ireland UC20221—
+3K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K201364LINK TrabecuLink Femoral ConesWaldemar Link GmbH & Co. KG20200—
+3K2000753DMetal Diaphyseal Femoral ConesMedacta International S.A.20200—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+3K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+3K1701493DMetal Tibial ConesMedacta International S.A.20170—
+3K153657Vanguard XP Knee SystemBiomet, Inc.201611
+3K153595Optetrak Logic Metaphyseal ConesExactech, Inc.20168—
+3K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+3K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+3K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+3K141840Trabecular Metal Tibial Cone Broach, Trabecular Metal Coupled Tibial Cone BroachZimmer, Inc.20140—
+3K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc.20140—
+3K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+3K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+3K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+3K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+3K123924Depuy Gription TF 5.5MM Sterile Locking ScrewsDepuy Orthopaedics20137—
+4K262057GMK ExtensionMedacta International SA20260—
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+4K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+4K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.20250—
+4K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+4K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+4K230295ATTUNE® Revision ConesDepuy Ireland UC20230—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—