510(k) Report

Devices descending from K102903

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—