510(k) Report

Devices descending from K024060

857 later devices reach Modification to Asnis Iii Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+3K110838Ifuse Implant SystemSI-BONE, Inc.2011143—
+3K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011241—
+3K093676Omnitech Large, Trimed Compression ScrewTriMed, Inc.201013—
+3K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+3K092189Pogo ScrewFxdevices20091—
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+3K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254280F.A.S.T ScrewSteps Ortho20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+4K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+4K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K230817TORPEDO Implant System®Deltacor GmbH20240—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+4K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K231831TiLink-L Joint Fusion SystemSurgentec20232—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+4K213815SiJoin®T3Vgi Medical, Inc.20230—
+4K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+4K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+4K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+4K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation20222—
+4K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+4K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+4K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+4K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+4K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—