510(k) Report

Devices descending from K033272

351 later devices reach Depuy Sigma Tibial Inserts through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+4K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+4K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+4K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+4K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+4K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation2009505
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+5K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+5K241470CORE Shoulder SystemLinkBio Corp.202501
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+5K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+5K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+5K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+5K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+5K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+5K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+5K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+5K191625Persona Revision Knee SystemZimmer, Inc.201911
+5K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+5K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+5K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+5K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+5K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163—
+5K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+5K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+5K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+5K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+5K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+5K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+5K131129Cas Psi ShoulderZimmer Cas201339—
+5K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+5K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+6K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+6K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+6K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+6K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+6K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+6K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+6K230078TRAX® CR Total Knee SystemAmplitude20230—
+6K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+6K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+6K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+6K203421Triathlon AS-1Conformis, Inc.20210—