510(k) Report

Devices descending from K041888

1,586 later devices reach Curved Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+8K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+8K152651AccuLIF TL and PL CageStryker Corporation201530—
+8K152304Tritanium PL CageStryker20154481
+8K151727Everest Spinal SystemK2m, Inc.201511—
+8K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+8K142360Everest Spinal SystemK2m, Inc.201522—
+8K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+8K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+8K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+8K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+8K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+8K141147Range Spinal SystemK2m, Inc.20141—
+8K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+8K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+8K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+8K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+8K130194Acculif XL CageCoalign Innovations, Inc.20131—
+8K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241895Cannulated PsiFGuardSpineguard20240—
+9K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+9K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+9K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+9K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+9K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+9K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+9K213815SiJoin®T3Vgi Medical, Inc.20230—
+9K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+9K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+9K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+9K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+9K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+9K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+9K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+9K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+9K182349Concorde LiftMedos International SARL20190—
+9K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+9K182584Lucent® XPSpinal Elements, Inc.20183—
+9K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+9K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+9K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+9K180376K2M Patient Specific RodsK2m, Inc.20182—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K173537Concorde Lift™Medos International SARL20181—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K171519FLXfit™Expanding Orthopedics, Inc.2017711
+9K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+9K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+9K162262Tritanium® PL CageStryker2016132—
+9K161028K2M Growing Spine SystemK2m, Inc.20163—
+9K161369EVEREST Spinal SystemK2m, Incorporated20169—
+9K160955Tritanium® PL CageStryker2016178—
+9K160715AccuLIF TL and PL CageStryker Corporation20160—
+9K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+9K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+9K151216Everest Spinal SystemK2m, Inc.201511—