510(k) Report

Devices descending from K023546

305 later devices reach Maxim Accel Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+3K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+4K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC20210—
+4K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+4K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+4K190100USTAR II SystemUnited Orthopedic Corporation201925
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+4K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+4K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+4K172651FMP Extended LinersEncore Medical L.P.20173—
+4K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+4K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+4K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161592Persona Partial Knee SystemBiomet, Inc.201652
+4K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+4K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+4K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+4K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+4K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+4K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+4K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+4K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+4K140830Exprt Revision KneeEncore Medical L.P.201471
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+4K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+4K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+4K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+4K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+5K261453G7® Acetabular SystemZimmer Biomet20260—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+5K251834Persona Partial KneeZimmer Biomet20250—
+5K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+5K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+5K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+5K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—