# K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web, Inc.
- Decided: Apr 9, 2015 after 147 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 K841189 (1984). 80 ancestors in all.
211 later devices descend from it; 6 cite it directly.
1 of 292 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 5.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 5.
- K103111: Forza Spacer System, Orthofix, Inc. (2011) Summary page 5.

## Most influential descendants
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages (2017), 199 descendants of its own
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages (2017), 159 descendants of its own
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF (2018), 141 descendants of its own
- K183447: EIT Cellular Titanium Lumbar Cage - T/PLIF (2019), 131 descendants of its own
- K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage (2020), 130 descendants of its own

## Indications for use
The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are 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/K143258
Methodology: https://510kreport.com/methodology