# K223251: Hexanium PLIF

- Pathway: 510(k) (Traditional)
- Applicant: Spinevision, S.A.S.
- Decided: Dec 16, 2022 after 56 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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). 222 ancestors in all.
No later device cites it as a predicate yet.
1 of 223 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210359: Hexanium TLIF, Spinevision, S.A.S. (2021) Summary page 4.
- K153783: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF, Spinevision S.A. (2016) Summary page 4.

## Indications for use
The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back 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 months of non-operative treatment prior to treatment with Hexanium PLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via the posterior approach. Hexanium PLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K223251
Methodology: https://510kreport.com/methodology