# K112316: 4-Web Alif Spinal Truss System (STS)

- Pathway: 510(k) (Special)
- Applicant: 4-Web, Inc.
- Decided: Dec 14, 2011 after 125 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010530 (2001). 8 ancestors in all.
537 later devices descend from it; 11 cite it directly.
0 of 546 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083894: Alif Spinal Truss Interbody Fusion Device, 4-Web Spine, LLC (2011) Summary page 2.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- K083626: Distractable Wave Cage, Advanced Medical Technology, Inc. (2009) Summary page 2.

## Most influential descendants
- K150481: Cascadia Interbody System (2015), 459 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K163230: NuVasive Modulus XLIF Interbody System (2017), 276 descendants of its own
- K172123: NuVasive® Modulus XLIF Interbody System (2017), 227 descendants of its own
- K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) (2015), 211 descendants of its own

## Recalls of this device
- Sep 29, 2014 · Class II · Z-0812-2015: Product is mislabeled.

## Indications for use
The ALIF Spinal Truss 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. 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/K112316
Methodology: https://510kreport.com/methodology