# K250603: AxTiHA® Stand-Alone ALIF System

- Pathway: 510(k) (Special)
- Applicant: Innovasis
- Decided: Mar 24, 2025 after 24 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: 25 generations back to K841189 (1984). 282 ancestors in all.
No later device cites it as a predicate yet.
1 of 283 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212967: AxTiHA Stand-Alone ALIF System, Innovasis, Inc. (2021) Summary page 5.
- K160605: MectaLIF Anterior Stand-Alone, Medacta International (2016) Summary page 5.

## Indications for use
The Innovasis AxTiHA Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K250603
Methodology: https://510kreport.com/methodology