# K200002: Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: 4Web, Inc.
- Decided: May 29, 2020 after 148 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
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 4WEB Anterior Spine Truss System (ASTS): named in the summary without a submission number
- (no number) 4WEB Cervical Spine Truss System – Stand Alone: named in the summary without a submission number
- (no number) Globus Independence Spacers: named in the summary without a submission number
- (no number) Titan Endoskeleton TAS Interbody Fusion Device: named in the summary without a submission number

## Most influential descendants
- K201585: Monterey AL Interbody System (2020), 4 descendants of its own
- K250072: CONDUIT™ SYNFIX™ Evolution Secured Spacer System (2025), 1 descendant of its own
- K233966: Anterior Spine Truss System-Stand Alone (ASTS-SA) (2024), 1 descendant of its own
- K221490: Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (2023), 1 descendant of its own
- K262061: Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM (2026), 0 descendants of its own

## Indications for use
The Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device is a standalone 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 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.

Source page: https://510kreport.com/device/K200002
Methodology: https://510kreport.com/methodology