510(k) Report

Devices descending from K133221

150 later devices reach Arsenal Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—