510(k) Report

Devices descending from K061340

47 later devices reach 23 MM Single-Peg Patella Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+2K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+2K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+2K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+2K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+2K210554Physica systemLima Corporate S.P.A.20212—
+2K201084Physica systemLima Corporate S.P.A.20205—
+2K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+2K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+2K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+2K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+2K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+2K153657Vanguard XP Knee SystemBiomet, Inc.201611
+2K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+2K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+2K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+2K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+2K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+2K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+3K262057GMK ExtensionMedacta International SA20260—
+3K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+3K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+3K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+3K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+3K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+3K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+3K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+3K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+3K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+3K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K211938Physica LMC Knee SystemLimacorporate20210—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+3K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+3K143635KINETIS Total Knee SystemMako Surgical20150—
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101