# K171351: Posterior Spine Truss System (PSTS) Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: 4Web, Inc.
- Decided: Sep 8, 2017 after 122 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: 19 generations back to K841189 (1984). 256 ancestors in all.
7 later devices descend from it; 3 cite it directly.
1 of 264 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System), 4Web, Inc. (2015) Summary page 5.
- K142112: 4WEB Spinal Implant Products, 4Web, Inc. (2014) Summary page 5.
- K160924: Amendia Interbody Fusion Devices, Amendia, Inc. (2016) Summary page 5.

## Most influential descendants
- K210595: SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers (2021), 3 descendants of its own
- K180990: TirboLOX-L Lumbar IBFD (2018), 1 descendant of its own
- K250335: IVA & AEON Cervical and Lumbar Cage System (2025), 0 descendants of its own
- K232256: Alcantara Thoracolumbar Plate System (2024), 0 descendants of its own
- K221324: ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) (2023), 0 descendants of its own

## Indications for use
The Posterior Spine Truss System (PSTS) 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 and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Source page: https://510kreport.com/device/K171351
Methodology: https://510kreport.com/methodology