510(k) Report

Devices descending from K091873

106 later devices reach Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200312Tryptik TiSpineart20202—
+1K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+1K172065Scarlet AC-TSpineart20172—
+1K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+1K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+1K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+1K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+1K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+1K112801Ayers Rock Cervical CageQualgenix20122—
+1K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+2K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+2K240699SCARLET® AC-TiSpineart SA20240—
+2K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+2K230583Tryptik TiSpineart SA20231—
+2K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+2K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+2K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+2K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+2K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K163265Kepler IIOrbbo Surgical, LLC20170—
+2K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+2K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+2K112862Mecta-CMedacta International201114—
+2K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+3K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K243188Cylox® STSignus Medizintechnik GmbH20250—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+6K223326Axiom PSR SystemRestor3D202301
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—