# K191516: Ali Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Raed M. Ali, M.D., Inc.
- Decided: Sep 12, 2019 after 97 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 summary cites 4 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0706: Exactech P-Stand Interbody Fusion Device. Number could not be read
- K0987: Zimmer Biomet InFix. Number could not be read
- K7087: NuVasive CoRoent Interbody Devices. Number could not be read
- K0888: TranS1 Interbody Fusion System. Number could not be read

## 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 L1-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/K191516
Methodology: https://510kreport.com/methodology