# K231781: OptiMesh Multiplanar Expandable Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: Oct 18, 2023 after 124 days
- Product code: OQB (Intervertebral Body Graft Containment Device)
- Device class: 2
- Regulation: 21 CFR 888.3085
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200010 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200010: Spineology Interbody Fusion System, Spineology, Inc. (2020) Summary page 4.

## Indications for use
The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade T spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

Source page: https://510kreport.com/device/K231781
Methodology: https://510kreport.com/methodology