510(k) Report

Devices descending from K954330

464 later devices reach Super Screw 3.5 MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+6K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+6K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+6K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+7K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—