510(k) Report

Devices descending from K162262

132 later devices reach Tritanium® PL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+9K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+9K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+10K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+10K223326Axiom PSR SystemRestor3D202301
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—