510(k) Report

Devices descending from K884824

79 later devices reach Tricon-M Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030623Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc.200378—
+2K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+2K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+2K100897Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc.201012—
+2K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.200514—
+2K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+3K210554Physica systemLima Corporate S.P.A.20212—
+3K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+3K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+3K142933Biomet Tibial traysBiomet, Inc.201463
+3K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+3K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+3K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+3K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+3K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+3K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+3K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp200647—
+3K041872Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral PegsBiomet Manufacturing Corp20040—
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+4K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+4K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+4K201084Physica systemLima Corporate S.P.A.20205—
+4K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+4K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+4K181947Persona Revision Knee SystemZimmer, Inc.201841
+4K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+4K153657Vanguard XP Knee SystemBiomet, Inc.201611
+4K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+4K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+4K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+4K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+4K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+4K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+4K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+4K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+5K262057GMK ExtensionMedacta International SA20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+5K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+5K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+5K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+5K191625Persona Revision Knee SystemZimmer, Inc.201911
+5K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+5K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+5K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+5K143635KINETIS Total Knee SystemMako Surgical20150—
+5K140257Signature Planner, Signature GuidesMaterialise NV20140—
+5K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K210551Persona Revision Knee SystemZimmer, Inc.202101
+6K153437Apex Revision Knee SystemOmnilife Science201541
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+7K163332Apex Revision Knee SystemOmnilife Science20173—
+8K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+9K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+9K201611Apex Knee SystemOmnilife Science20210—