# K210590: Axis Spine Technologies ALIF

- Pathway: 510(k) (Traditional)
- Applicant: Axis Spine Technologies, Ltd.
- Decided: Sep 29, 2021 after 212 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 21 generations back to K841189 (1984). 236 ancestors in all.
No later device cites it as a predicate yet.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160597: INDEPENDENCE MIS Spacers, Globus Medical, Inc. (2016) Summary page 5.
- K200352: Axis Spine Technologies ALIF, Axis Spine Technologies, Ltd. (2020) Summary page 6.
- K132596: Proposed Optimus, Custom Spine, Inc. (2014) Summary page 6.
- K170592: NuVasive BASE Interfixated Titanium System, Nu Vasive, Incorporated (2017) Summary page 6.

## Indications for use
The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to -Sl. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The ALIF System 100 - 200 lordotic cages may be used as a standalone system. The ALIF System 250 - 400 lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K210590
Methodology: https://510kreport.com/methodology