510(k) Report

Devices descending from K000080

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254280F.A.S.T ScrewSteps Ortho20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+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—
+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—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+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—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+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—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+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—
+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—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+4K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+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—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+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—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+4K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, 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—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—