510(k) Report

Devices descending from K032371

26 later devices reach Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K172323Omnia Medical VBROmnia Medical, LLC20176—
+2K111294Santorini Spinal SystemK2m, Inc.201218—
+2K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+3K191778Omnia Medical VBROmnia Medical, LLC20195—
+3K171704CAPRI Corpectomy Cage SystemK2m201710—
+3K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K142016CAPRIK2m, Inc.201412—
+3K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+4K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—