510(k) Report

Devices descending from K042714

838 later devices reach Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+9K182584Lucent® XPSpinal Elements, Inc.20183—
+9K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+9K172816TiGer Shark™ SystemChoicespine, LP201859—
+9K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+9K172419Velofix™ TLIF CageU&I Corporation20172—
+9K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K234150Lucent® XPSpinal Elements20240—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+10K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+10K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+10K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+10K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+10K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+10K183243Velofix TLIF CageU&I Corporation20190—
+10K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+10K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+10K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+10K181829Velofix TLIF CageU&I Corporation20181—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+11K202637F3D Corpectomy SystemCorelink, LLC20201—
+11K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+12K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—