510(k) Report

Devices descending from K163595

28 later devices reach IMPIX 3D Print Cages through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+1K191134IB3D AlifMedicrea International SA20191—
+1K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+1K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+1K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+2K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+2K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+2K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+2K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+2K200316UNiD IB3D ALIFMedicrea International SA20200—
+3K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+4K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+4K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+4K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+4K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—