# K200352: Axis Spine Technologies ALIF

- Pathway: 510(k) (Traditional)
- Applicant: Axis Spine Technologies, Ltd.
- Decided: May 20, 2020 after 97 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: 20 generations back to K841189 (1984). 230 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132596: Proposed Optimus, Custom Spine, Inc. (2014) Summary page 5.
- K170592: NuVasive BASE Interfixated Titanium System, Nu Vasive, Incorporated (2017) Summary page 5.

## Most influential descendants
- K210590: Axis Spine Technologies ALIF (2021), 0 descendants of its own
- K202820: Australis Anterior Lumbar Cage System (2020), 0 descendants of its own

## 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 S1. 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 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. 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/K200352
Methodology: https://510kreport.com/methodology