# K153436: LATERAL Spine Truss System

- Pathway: 510(k) (Traditional)
- Applicant: 4Web, Inc.
- Decided: Jun 6, 2016 after 192 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: 15 generations back to K841189 (1984). 101 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 107 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112316: 4-Web Alif Spinal Truss System (STS), 4-Web, Inc. (2011) Summary page 4.
- K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System), 4Web, Inc. (2015) Summary page 4.
- K083894: Alif Spinal Truss Interbody Fusion Device, 4-Web Spine, LLC (2011) Summary page 4.
- K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.

## Most influential descendants
- K220523: restor3d TiDAL Lumbar Interbody Fusion Device (2022), 2 descendants of its own
- K172392: Lateral Spinal Truss System (LSTS) Interbody Fusion Device (2017), 1 descendant of its own
- K234087: restor3d TIDAL Lumbar Interbody Fusion System (2024), 0 descendants of its own
- K223326: Axiom PSR System (2023), 0 descendants of its own
- K211388: Lateral Spine Truss System (LSTS) Interbody Fusion Device (2021), 0 descendants of its own

## Indications for use
The Lateral Spine Truss System (STS) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. 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. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Source page: https://510kreport.com/device/K153436
Methodology: https://510kreport.com/methodology