510(k) Report

Devices descending from K172941

52 later devices reach CASCADIA Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+1K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+1K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+1K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+1K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+1K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+1K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+1K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+2K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+2K253545Vulcan Spinal SystemK2m, Inc.20260—
+2K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+2K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+2K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+2K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+2K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K211306LabyrinthZavation Medical Products, LLC20213—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—