Devices descending from K193000
14 later devices reach Hexanium® ACIF through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K221578 | Hexanium ACIF | Spinevision, S.A.S. | 2022 | 4 | — |
| +1 | K211111 | SureMAX-SA Cervical Standalone System | Additive Implants, Inc. | 2021 | 8 | — |
| +2 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | 3 | — |
| +2 | K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty), Ltd. | 2023 | 0 | — |
| +2 | K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022 | 5 | — |
| +2 | K222903 | Tailored-H Cervical Stand Alone System | Bespoke Technologies, LLC | 2022 | 0 | — |
| +3 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion… | Carlsmed, Inc. | 2025 | 2 | — |
| +3 | K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025 | 0 | — |
| +3 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | 3 | — |
| +4 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | 0 | — |
| +4 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | 1 | — |
| +4 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | 2 | — |
| +5 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | 1 | — |
| +6 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | 0 | — |