510(k) Report

Devices descending from K980288

959 later devices reach Spine-Tech Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+6K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+6K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+6K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+6K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+6K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+6K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+6K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+6K083743Capsure PS SystemSpine Wave, Inc.20093—
+6K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253249TriALTIS™ Spine SystemMedos International SARL20251—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+7K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K241258Ingenix Spinal SystemIngenium Spine20240—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K231515MySpine Cervical GuidesMedacta International S.A.20230—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+7K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—