Devices descending from P000028
1,287 later devices reach Affinity (TM) Cage System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +5 | K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023 | 0 | — |
| +5 | K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | MiRus, LLC | 2023 | 0 | — |
| +5 | K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | 2023 | 2 | — |
| +5 | K231275 | Exceed™ Biplanar Expandable Interbody System | Spine Wave, Inc. | 2023 | 2 | — |
| +5 | K231241 | NanoHive Medical Lumbar Interbody System | NanoHive Medical, LLC | 2023 | 0 | — |
| +5 | K231252 | Ventana™ L Spinal System | Spinal Elements, Inc. | 2023 | 1 | — |
| +5 | K230894 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2023 | 4 | — |
| +5 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®… | Stryker Spine | 2023 | 4 | — |
| +5 | K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior… | Gbs Commonwealth Co., Ltd. | 2023 | 3 | — |
| +5 | K222833 | Ventana™ C Spinal System | Spinal Elements, Inc. | 2023 | 4 | — |
| +5 | K230414 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023 | 3 | — |
| +5 | K223335 | SIRION Lateral Lumbar Interbody System | Astura Medical | 2023 | 0 | — |
| +5 | K223868 | PYXIS 3D Titanium Cage System | GS Medical Co., Ltd. | 2023 | 2 | — |
| +5 | K220261 | NEST-C Interbody System | Paonan Biotech Co., Ltd. | 2023 | 0 | — |
| +5 | K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | 2023 | 0 | — |
| +5 | K223513 | UniVy™ OsteoVy™-Ti Cervical IBF System | Vy Spine, LLC | 2023 | 1 | — |
| +5 | K223326 | Axiom PSR System | Restor3D | 2023 | 0 | 1 |
| +5 | K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023 | 3 | — |
| +5 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | 17 | — |
| +5 | K221542 | Galileo Vertebral Body Replacement Device | Bright Spine | 2023 | 0 | — |
| +5 | K223474 | PathLoc-TA Expandable Lumbar Cage System | L&K BIOMED Co., Ltd. | 2023 | 1 | — |
| +5 | K223140 | AEON-C™ Stand Alone System | Dio Medical, Inc. | 2022 | 2 | — |
| +5 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | 14 | — |
| +5 | K223510 | Matrix HA Fusion Porous Cervical IBF System | Innovasis, Inc. | 2022 | 0 | — |
| +5 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022 | 1 | — |
| +5 | K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022 | 8 | — |
| +5 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System… | Alphatec Spine, Inc. | 2022 | 13 | — |
| +5 | K212612 | Omnia Medical TiBrid-SC | Omnia Medical, LLC | 2022 | 0 | — |
| +5 | K220334 | MONET Anterior Cervical Plate System | Ctl Medical Corporation | 2022 | 0 | — |
| +5 | K221162 | UniVy OsteoVy Cervical IBF System | Vy Spine, LLC | 2022 | 2 | — |
| +5 | K223065 | Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices | Adcura, Inc. | 2022 | 0 | — |
| +5 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS… | Globus Medical, Inc. | 2022 | 23 | — |
| +5 | K221172 | FOCUS Interbody System | Oc Medical Devices | 2022 | 0 | — |
| +5 | K221447 | Southern Anterior Screw Fixated Cage (SASCA) | Southern Medical (Pty), Ltd. | 2022 | 0 | — |
| +5 | K221858 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2022 | 4 | — |
| +5 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | Alphatec Spine | 2022 | 28 | — |
| +5 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™… | Medtronic Sofamor Danek USA, Inc. | 2022 | 20 | — |
| +5 | K222561 | Align | Acuity Surgical Devices, LLC | 2022 | 14 | — |
| +5 | K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Innovasis, Inc. | 2022 | 4 | — |
| +5 | K221535 | Align Lumbar Interbody Fusion System | Acuity Surgical Devices, LLC | 2022 | 3 | — |
| +5 | K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | Nu Vasive, Incorporated | 2022 | 2 | — |
| +5 | K220581 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | 2022 | 4 | — |
| +5 | K220610 | SOLO-L | Aurora Spine, Inc. | 2022 | 0 | — |
| +5 | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | 2022 | 10 | — |
| +5 | K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2022 | 4 | — |
| +5 | K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | 2022 | 4 | — |
| +5 | K214011 | Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal… | Medtronic Sofamor Danek USA, Inc. | 2022 | 1 | — |
| +5 | K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | 2022 | 2 | — |
| +5 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2021 | 66 | — |
| +5 | K212715 | Vy Spine ClariVy Cervical IBF System | Vy Spine, LLC | 2021 | 6 | — |
| +5 | K212904 | SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2021 | 15 | — |
| +5 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | 55 | — |
| +5 | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | 1 | — |
| +5 | K211845 | Deploy Expandable Interbody System | Southern Spine, LLC | 2021 | 0 | — |
| +5 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec… | Alphatec Spine, Inc. | 2021 | 38 | — |
| +5 | K211474 | Kleiner KG2 System | BAAT Medical Products B.V. | 2021 | 0 | — |
| +5 | K201793 | EDEN Peek Cage | Jmt Co., Ltd. | 2021 | 0 | — |
| +5 | K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer… | Orthofix, Inc. | 2021 | 5 | — |
| +5 | K210090 | Impulse AM Interbody Fusion System | Degen Medical | 2021 | 7 | — |
| +5 | K210800 | IO Expandable Lumbar Interbody Fusion System | MiRus, LLC | 2021 | 2 | — |
| +5 | K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021 | 11 | — |
| +5 | K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Camber Spine Technologies, LLC | 2021 | 3 | — |
| +5 | K210583 | SeaSpine WaveForm™ A Interbody System | SeaSpine Orthopedics Corporation | 2021 | 14 | — |
| +5 | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA… | Medtronic Sofamor Danek USA, Inc. | 2021 | 75 | — |
| +5 | K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System | Nu Vasive, Incorporated | 2021 | 3 | — |
| +5 | K210439 | NuVasive MOD-EX XLIF Interbody System | Nu Vasive, Incorporated | 2021 | 4 | — |
| +5 | K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021 | 3 | — |
| +5 | K200919 | Idys ALIF 3DTi | Clariance | 2021 | 0 | — |
| +5 | K202032 | Idys LLIF 3DTi | Clariance, Sas | 2021 | 0 | — |
| +5 | K210359 | Hexanium TLIF | Spinevision, S.A.S. | 2021 | 1 | — |
| +5 | K210271 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2021 | 5 | — |
| +5 | K202380 | Born PT-LIF Cage HA | Spineworxx AG | 2021 | 0 | — |
| +5 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental… | Globus Medical, Inc. | 2021 | 35 | — |
| +5 | K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System | SeaSpine Orthopedics Corporation | 2020 | 17 | — |
| +5 | K202230 | NEXXT MATRIXX Stand Alone ALIF System | Nexxt Spine, LLC | 2020 | 0 | — |
| +5 | K201692 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2020 | 67 | — |
| +5 | K201506 | Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical… | Meditech Spine, LLC | 2020 | 0 | — |
| +5 | K200958 | MODULIF-A Anterior Lumbar Interbody Fusion System | Spinal Stability, LLC | 2020 | 0 | — |
| +5 | K201087 | CORBEL Spacers | Globus Medical, Inc. | 2020 | 36 | — |
| +5 | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular… | Eit Emerging Implant Technologies GmbH | 2020 | 130 | — |
| +5 | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2020 | 47 | 1 |
| +5 | K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2020 | 60 | — |
| +5 | K200920 | Idys ALIF ZP 3DTi | Clariance, Sas | 2020 | 3 | — |
| +5 | K200969 | NEXXT MATRIXX System | Nexxt Spine, LLC | 2020 | 0 | — |
| +5 | K191906 | MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed… | MiRus, LLC | 2020 | 6 | — |
| +5 | K200991 | EVOL Spinal Interbody System | Cutting Edge Spine, LLC | 2020 | 0 | — |
| +5 | K200816 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | 2020 | 1 | — |
| +5 | K200338 | ProLift Lateral Fixated | Life Spine, Inc. | 2020 | 5 | — |
| +5 | K193541 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2020 | 157 | — |
| +5 | K193412 | NEXXT MATRIXX System | Nexxt Spine, LLC | 2020 | 1 | — |
| +5 | K193203 | MOJAVE Expandable Interbody System | K2m, Inc. | 2020 | 15 | — |
| +5 | K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | 2020 | 3 | — |
| +5 | K193370 | Nexxt Matrixx System | Nexxt Spine, LLC | 2020 | 2 | — |
| +5 | K192687 | TrellOss™-L MPF | Nexxt Spine, LLC | 2020 | 1 | — |
| +5 | K191796 | Neo Cage System | Neo Medical SA | 2019 | 0 | — |
| +5 | K192168 | Idys ALIF ZP 3DTi | Clariance, Sas | 2019 | 5 | — |
| +5 | K191134 | IB3D Alif | Medicrea International SA | 2019 | 1 | — |
| +5 | K192760 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2019 | 163 | — |
| +5 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | 84 | — |
| +5 | K183407 | Triton Cage | Medyssey USA, Inc. | 2019 | 0 | — |