510(k) Report

Devices descending from K020791

336 later devices reach HBS Headless Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+9K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+9K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+10K240487EVOS Patella PlatesSmith & Nephew20240—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+10K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+10K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+11K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+12K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+13K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+14K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—