# K261809: Interwedge® Standalone Lateral

- Pathway: 510(k) (Special)
- Applicant: Foundation Surgical Group
- Decided: Jul 31, 2026 after 60 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: 28 generations back to K841189 (1984). 557 ancestors in all.
No later device cites it as a predicate yet.
1 of 558 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241487: Interwedge® Standalone Lateral, Foundation Surgical Group, Inc. (2024) Summary page 5.

## Indications for use
The Interwedge® Standalone Lateral is a standalone lateral lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L1-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Interwedge® Standalone Lateral is to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone, and is to be used with the two titanium alloy screws which accompany the implant. Should a physician choose to use fewer than these two screws, additional supplemental fixation must be used to augment stability.

Source page: https://510kreport.com/device/K261809
Methodology: https://510kreport.com/methodology