510(k) Report

Devices descending from K040166

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+4K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+4K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163—
+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—
+4K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+4K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+4K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+4K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+4K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+4K131129Cas Psi ShoulderZimmer Cas201339—
+4K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+4K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+5K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+5K201084Physica systemLima Corporate S.P.A.20205—
+5K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.20201—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+5K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+5K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+5K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+5K171365Arthrex Knee SystemsArthrex, Inc.20170—
+5K163669Humeris ShoulderFx Solutions201720—
+5K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+5K162455Humelock Reversed ShoulderFx Solutions201717—
+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—
+5K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+5K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+5K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+5K150730Zimmer PSI Shoulder SystemZimmer201511—
+5K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+5K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.201525—
+5K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212