510(k) Report

Devices descending from K051978

22 later devices reach Trabecular Metal Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052950The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular200521—
+2K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+3K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K210573Velofix SA Cervical CageU&I Corporation20211—
+5K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+5K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—