# K142112: 4WEB Spinal Implant Products

- Pathway: 510(k) (Special)
- Applicant: 4Web, Inc.
- Decided: Sep 23, 2014 after 50 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: 14 generations back to K003155 (2001). 62 ancestors in all.
33 later devices descend from it; 6 cite it directly.
0 of 96 devices in its family (counting itself) have 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.
- K121741: 4-Web Cervical STS (Spinal Truss System), 4-Web, Inc. (2012) Summary page 4.

## Most influential descendants
- K173159: Cervical Spinal Truss System (CSTS) Interbody Fusion Device (2018), 12 descendants of its own
- K190870: Cervical Spinal Truss System-Stand Alone (CSTS-SA) (2019), 10 descendants of its own
- K171351: Posterior Spine Truss System (PSTS) Interbody Fusion Device (2017), 7 descendants of its own
- K172446: SPIRA-C Open Matrix Cervical Interbody (2017), 6 descendants of its own
- K170851: Anterior Spine Truss System (STS) Interbody Fusion Device (2017), 5 descendants of its own

## Indications for use
The ALIF STS 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). The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

Source page: https://510kreport.com/device/K142112
Methodology: https://510kreport.com/methodology