510(k) Report

Devices descending from K111571

203 later devices reach Viper Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K171321K2M Navigation InstrumentsK2m201711
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K151727Everest Spinal SystemK2m, Inc.201511—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+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—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—