510(k) Report

Devices descending from K810205

182 later devices reach Mecron Cancellous Cannulated Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+7K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+7K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+8K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+10K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—