# K211388: Lateral Spine Truss System (LSTS) Interbody Fusion Device

- Pathway: 510(k) (Special)
- Applicant: 4Web Medical, Inc.
- Decided: Aug 5, 2021 after 92 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: 20 generations back to K841189 (1984). 259 ancestors in all.
No later device cites it as a predicate yet.
1 of 260 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172392: Lateral Spinal Truss System (LSTS) Interbody Fusion Device, 4Web, Inc. (2017) Summary page 5.

## Indications for use
The Lateral Spine Truss System (LSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. All LSTS Interbody Fusion Devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Interbodies with 18° lordosis or greater must be used with the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) with integrated fixation. If using the 1-hole 4WEB LSTS-PS with integrated fixation, additional supplemental fixation is required (e.g. posterior fixation). These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Source page: https://510kreport.com/device/K211388
Methodology: https://510kreport.com/methodology