# K233966: Anterior Spine Truss System-Stand Alone (ASTS-SA)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web Medical, Inc.
- Decided: Apr 22, 2024 after 129 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 25 generations back to K841189 (1984). 430 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 432 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200002: Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device, 4Web, Inc. (2020) Summary page 5.
- K223362: Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device, 4Web Medical, Inc. (2023) Summary page 5.

## Most influential descendants
- K243934: Stable-L Lumbar Interbody System (2025), 0 descendants of its own

## Indications for use
The Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device is a stand-alone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at one or two contiguous disc levels. Each interbody fusion device is intended to be used with three titanium alloy screws or anchors which accompany the implant. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g. posterior fixation). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. ASTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the lumbosacral spine and are placed via an anterior approach at the L2 to S1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). When using the ASTS-SA Interbody with fixation anchors, the device must be used with supplemental fixation.

Source page: https://510kreport.com/device/K233966
Methodology: https://510kreport.com/methodology