510(k) Report

Devices descending from K090949

176 later devices reach Synthes (Usa) 1.5MM Headless Compression Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—