Devices descending from K013534
241 later devices reach Self-Countersinking Bone Screw through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +6 | K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 | 3 | — |
| +6 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | 18 | — |
| +6 | K212562 | Idys-C ZP 3DTi | Clariance, SA | 2021 | 1 | — |
| +6 | K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021 | 3 | — |
| +6 | K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | Precision Spine, Inc. | 2021 | 0 | — |
| +6 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 | 25 | — |
| +6 | K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 4Web, Inc. | 2019 | 10 | — |
| +6 | K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | 2019 | 93 | — |
| +6 | K173102 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017 | 15 | — |
| +6 | K171075 | Calix-C Cervical Interbody Spacer | X-Spine Systems, Inc. | 2017 | 15 | — |
| +6 | K170830 | Unison-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2017 | 5 | — |
| +6 | K152622 | Alta ACDF System | Biomet Spine | 2016 | 0 | — |
| +6 | K142269 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2015 | 23 | — |
| +7 | K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026 | 0 | — |
| +7 | K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026 | 0 | — |
| +7 | K242303 | MOD-C | Orthomod, LLC | 2026 | 0 | — |
| +7 | K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025 | 1 | — |
| +7 | K240838 | Spectrum Spine Cervical Cage System | Spectrum Spine, Inc. | 2024 | 4 | — |
| +7 | K232348 | RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System | MiRus, LLC | 2023 | 1 | — |
| +7 | K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | 2023 | 2 | — |
| +7 | K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty), Ltd. | 2023 | 0 | — |
| +7 | K230329 | F3D Interbody System | Corelink, LLC | 2023 | 0 | — |
| +7 | K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2023 | 2 | — |
| +7 | K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | 2023 | 3 | — |
| +7 | K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022 | 5 | — |
| +7 | K223190 | Hive™ Standalone Cervical System | NanoHive Medical, LLC | 2022 | 5 | — |
| +7 | K222903 | Tailored-H Cervical Stand Alone System | Bespoke Technologies, LLC | 2022 | 0 | — |
| +7 | K221162 | UniVy OsteoVy Cervical IBF System | Vy Spine, LLC | 2022 | 2 | — |
| +7 | K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | 4Web Medical, Inc. | 2022 | 0 | — |
| +7 | K212358 | Romero Cervical Cage | Spineup, Inc. | 2022 | 6 | — |
| +7 | K212715 | Vy Spine ClariVy Cervical IBF System | Vy Spine, LLC | 2021 | 6 | — |
| +7 | K203520 | Blustone Synergy Interbody Fusion System | Blustone Synergy, LLC | 2021 | 0 | — |
| +7 | K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2021 | 9 | — |
| +7 | K193000 | Hexanium® ACIF | Spinevision, S.A.S. | 2020 | 14 | — |
| +7 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | 9 | — |
| +7 | K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | 2020 | 4 | — |
| +7 | K193153 | SPIRA-C Integrated Fixation System | Camber Spine Technologies | 2020 | 2 | — |
| +7 | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | 2020 | 72 | — |
| +7 | K173832 | InTice™-C Porous Ti Cervical Interbody System | X-Spine Systems, Inc. | 2018 | 0 | 1 |
| +7 | K172489 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017 | 16 | — |
| +7 | K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System | Precision Spine, Inc. | 2016 | 5 | — |
| +8 | K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026 | 0 | — |
| +8 | K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026 | 0 | — |
| +8 | K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | 2026 | 0 | — |
| +8 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026 | 0 | — |
| +8 | K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | 2026 | 0 | — |
| +8 | K252781 | MSFX Mikron Peek Cages | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025 | 1 | — |
| +8 | K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025 | 0 | — |
| +8 | K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025 | 0 | — |
| +8 | K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | 2025 | 0 | — |
| +8 | K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025 | 0 | — |
| +8 | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 | 2 | — |
| +8 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | 3 | — |
| +8 | K233807 | LumiVy™ Lumbar IBF System | Vy Spine, LLC | 2024 | 1 | — |
| +8 | K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | 2024 | 4 | — |
| +8 | K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | 2024 | 1 | — |
| +8 | K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | 1 | — |
| +8 | K231836 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023 | 2 | — |
| +8 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | 3 | — |
| +8 | K230414 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023 | 3 | — |
| +8 | K223513 | UniVy™ OsteoVy™-Ti Cervical IBF System | Vy Spine, LLC | 2023 | 1 | — |
| +8 | K230026 | Squale | Implanet, S.A. | 2023 | 0 | — |
| +8 | K223837 | SPIRA®-C Integrated Fixation System | Camber Spine Technologies | 2023 | 0 | — |
| +8 | K221578 | Hexanium ACIF | Spinevision, S.A.S. | 2022 | 4 | — |
| +8 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | 6 | — |
| +8 | K212811 | Ti3Z Lumbar Interbody System | Zavation Medical Products, LLC | 2022 | 3 | — |
| +8 | K211111 | SureMAX-SA Cervical Standalone System | Additive Implants, Inc. | 2021 | 8 | — |
| +8 | K211306 | Labyrinth | Zavation Medical Products, LLC | 2021 | 3 | — |
| +8 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | 67 | — |
| +8 | K171657 | ShurFit 2C Lumbar Interbody Fusion System | Precision Spine, Inc. | 2017 | 4 | — |
| +9 | K260340 | HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC… | HC Biologics, LLC | 2026 | 0 | — |
| +9 | K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 2025 | 1 | — |
| +9 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion… | Carlsmed, Inc. | 2025 | 2 | — |
| +9 | K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025 | 0 | — |
| +9 | K241783 | FortiVy™ OsteoVy™ Lumbar IBF | Vy Spine, LLC | 2025 | 0 | — |
| +9 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | 2 | — |
| +9 | K240703 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | 0 | — |
| +9 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System… | Zavation Medical Products, LLC | 2024 | 1 | — |
| +9 | K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023 | 2 | — |
| +9 | K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty), Ltd. | 2022 | 0 | — |
| +9 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | Alphatec Spine, Inc. | 2022 | 36 | — |
| +9 | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | 1 | — |
| +9 | K212070 | KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. | 2021 | 0 | — |
| +9 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | 59 | — |
| +10 | K260850 | Osteomni Spinal Cages System | Osteomni, Inc. | 2026 | 0 | — |
| +10 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | 0 | — |
| +10 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | 1 | — |
| +10 | K250769 | Dakota LP System | Precision Spine, Inc. | 2025 | 0 | — |
| +10 | K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | Alphatec Spine | 2025 | 0 | — |
| +10 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | 1 | — |
| +10 | K232432 | E3D™-A Interbody System | Evolution Spine | 2024 | 8 | — |
| +10 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System… | Alphatec Spine, Inc. | 2022 | 13 | — |
| +10 | K221172 | FOCUS Interbody System | Oc Medical Devices | 2022 | 0 | — |
| +10 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | Alphatec Spine | 2022 | 28 | — |
| +10 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | 12 | — |
| +10 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | 16 | — |
| +11 | K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | 2026 | 0 | — |
| +11 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | 0 | — |
| +11 | K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025 | 1 | — |
| +11 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi… | Alphatec Spine | 2025 | 3 | — |