510(k) Report

Devices descending from K112405

296 later devices reach Clydesdales Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+6K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+6K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+6K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K220025ARx® Spinal SystemLife Spine, Inc.20220—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+9K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—