# K200958: MODULIF-A Anterior Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Stability, LLC
- Decided: Aug 28, 2020 after 140 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
Longest line of descent: 21 generations back to K841189 (1984). 215 ancestors in all.
No later device cites it as a predicate yet.
1 of 216 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132790: Infix Anterior Lumbar System, Zimmer Spine, Inc. (2013) Summary page 4.
- K111166: A-Wedge Anterior Interbody System (a-Wedge a.I.S.), Spineworks, LLC (2011) Summary page 4.
- K163364: MOJAVE Expandable Interbody System, K2m (2017) Summary page 4.
- K143143: Pathway Elif, Custom Spine, Inc. (2015) Summary page 4.

## Indications for use
MODULIF-A is an interbody fusion device intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may have up to Grade | spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal procedure at the involved level(s). The device system is designed for use with supplemental fixation and with autogenous or allograft bone graft comprised of cancellous and / or corticocancellous bone graft to facilitate fusion. Patients should have six months of non-operative treatment prior to treatment with an interbody fusion cage. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device.

Source page: https://510kreport.com/device/K200958
Methodology: https://510kreport.com/methodology