510(k) Report

Devices descending from K121020

94 later devices reach Viper System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+1K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+1K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+2K252322SIros-X SystemGenesys Spine20250—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+2K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+2K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+2K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+2K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+2K172115Navigated Instrument SystemOrthofix, Inc.20184—
+2K162921Navigated Instrument SystemOrthofix, Inc.20175—
+2K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+2K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182470Plateau Spacer SystemLife Spine20180—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—