510(k) Report

Devices descending from K003496

345 later devices reach Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+6K190230iFuse Implant System®SI-BONE, Inc.201957—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+7K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+7K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K251365OptumSI Implant SystemSi Solutions, LLC20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—