510(k) Report

Devices descending from K040168

239 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+13K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+13K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+13K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+13K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+13K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+13K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+13K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+13K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+13K240368E3D™-A Interbody SystemEvolution Spine20247—
+13K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+13K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+13K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+13K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+13K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+13K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+13K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+13K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+13K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+14K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+14K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+14K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+14K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+14K252322SIros-X SystemGenesys Spine20250—
+14K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+14K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+14K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+14K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+14K241846E3D™-C Interbody SystemEvolution Spine20246—
+14K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+14K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+14K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+14K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+15K262094E3D™-C Interbody SystemEvolution Spine20260—
+15K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+15K260038E3D™-C Interbody SystemEvolution Spine20261—
+15K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+15K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+16K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—