510(k) Report

Devices descending from K222561

14 later devices reach Align through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+1K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+1K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+1K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+1K232432E3D™-A Interbody SystemEvolution Spine20248—
+2K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—