510(k) Report

Devices descending from K040166

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+6K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+6K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+6K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+6K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+6K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+6K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+6K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+6K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+7K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+7K243509Archer PSI System3D-Side20250—
+7K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+7K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+7K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+7K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+7K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+7K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+7K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+7K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+7K203421Triathlon AS-1Conformis, Inc.20210—
+7K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+7K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+7K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+7K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+7K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+8K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+8K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+8K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+8K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+8K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+8K210153NextAR RSA PlatformMedacta International S.A.202151
+8K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+8K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+8K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+9K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+9K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—