510(k) Report

Devices descending from K991581

348 later devices reach Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+4K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+4K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+4K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+4K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+4K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+4K153657Vanguard XP Knee SystemBiomet, Inc.201611
+4K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+4K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+4K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+4K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+4K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+4K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+4K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc.20153—
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K143635KINETIS Total Knee SystemMako Surgical20150—
+4K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+4K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147—
+4K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+4K140257Signature Planner, Signature GuidesMaterialise NV20140—
+4K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+4K132879Mpact ExtensionMedacta International201411—
+4K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+4K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+4K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+4K123486Triathlon Tritanium Tibial BaseplateStryker2013517
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsSmith & Nephew, Inc.201183
+4K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111—
+4K111145Endo HeadMedacta International20110—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+5K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+5K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+5K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+5K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K210554Physica systemLima Corporate S.P.A.20212—
+5K201611Apex Knee SystemOmnilife Science20210—
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+5K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+5K202152NextAR TKA PlatformMedacta International S.A.202011—
+5K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+5K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+5K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+5K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+5K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.20147—
+5K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics20142811
+5K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+5K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics2013381
+5K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial…Tgm Medical, Inc.20130—
+6K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+6K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+6K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+6K250477NextAR (TM) SpineMedacta International S.A.20250—
+6K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+6K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+6K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+6K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+6K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+6K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K223769NextAR™ Spine PlatformMedacta International S.A.20232—