# K193000: Hexanium® ACIF

- Pathway: 510(k) (Traditional)
- Applicant: Spinevision, S.A.S.
- Decided: Oct 20, 2020 after 358 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K841189 (1984). 318 ancestors in all.
14 later devices descend from it; 2 cite it directly.
1 of 333 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190546: NEXXT MATRIXX Stand Alone Cervical System, Nexxt Spine, LLC (2019) Summary page 4.
- K141314: Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation, Spineart (2014) Summary page 4.

## Most influential descendants
- K211111: SureMAX-SA Cervical Standalone System (2021), 8 descendants of its own
- K223105: Tesera-K SC System (2022), 5 descendants of its own
- K221578: Hexanium ACIF (2022), 4 descendants of its own
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 3 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own

## Indications for use
The Hexanium ACIF (Anterior Cervical Interbody Fusion) system is intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 weeks of non-operative treatment prior to treatment with Hexanium ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.

Source page: https://510kreport.com/device/K193000
Methodology: https://510kreport.com/methodology