# K203308: Ali Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Raed M. Ali, M.D., Inc.
- Decided: Jan 15, 2021 after 66 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ali Interbody Fusion System: named in the summary without a submission number

## Indications for use
The Ali Interbody Fusion System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from LI-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. The Ali Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Ali Interbody Fusion System is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K203308
Methodology: https://510kreport.com/methodology