510(k) Report

Devices descending from K915132

315 later devices reach MCK Maximum Congruent Knee) Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+4K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+4K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+4K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+4K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+4K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+4K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+4K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+4K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+4K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+4K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+4K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+4K121727Movation Knee SystemEncore Medical L.P.201214—
+4K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+4K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+4K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+4K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+4K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+5K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+5K190057DJO Acetabular SystemEncore Medical L.P.201925
+5K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+5K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+5K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+5K172651FMP Extended LinersEncore Medical L.P.20173—
+5K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+5K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+5K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+5K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+5K161592Persona Partial Knee SystemBiomet, Inc.201652
+5K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+5K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+5K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+5K153437Apex Revision Knee SystemOmnilife Science201541
+5K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+5K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+5K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+5K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+5K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+5K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+5K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+5K140830Exprt Revision KneeEncore Medical L.P.201471
+5K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+5K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+5K141006RSP Humeral Socket InsertDjo Global2014212
+5K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+5K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+5K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+5K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+5K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+5K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+5K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+6K261453G7® Acetabular SystemZimmer Biomet20260—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K251834Persona Partial KneeZimmer Biomet20250—
+6K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+6K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+6K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+6K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+6K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+6K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+6K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+6K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+6K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102