510(k) Report

Devices descending from K022793

1,705 later devices reach Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+10K130194Acculif XL CageCoalign Innovations, Inc.20131—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+11K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+11K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+11K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+11K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+11K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+11K241895Cannulated PsiFGuardSpineguard20240—
+11K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+11K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+11K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+11K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+11K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+11K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+11K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+11K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+11K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+11K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+11K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+11K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+11K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+11K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+11K213815SiJoin®T3Vgi Medical, Inc.20230—
+11K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+11K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+11K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+11K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+11K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+11K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+11K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+11K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+11K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+11K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+11K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+11K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+11K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+11K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+11K171519FLXfit™Expanding Orthopedics, Inc.2017711
+11K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+11K141217Acculif TL and PL CageStryker Corporation20146423
+12K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+12K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+12K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+12K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+12K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+12K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+12K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+12K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+12K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+12K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+12K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+12K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+12K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+12K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+12K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+12K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+12K230989Rod Registration FrameNu Vasive, Incorporated20230—
+12K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+12K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+12K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+12K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+12K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+12K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+12K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+12K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+12K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+13K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+13K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+13K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+13K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+13K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+13K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+13K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+13K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+13K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+13K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+13K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+13K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+13K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+13K191575ARx Spinal SystemLife Spine, Inc.201910—
+14K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+14K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+14K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+14K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+14K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+14K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+14K220025ARx® Spinal SystemLife Spine, Inc.20220—
+14K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+14K200070ARx Spinal SystemLife Spine, Inc.20209—
+15K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+15K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+15K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+15K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—