# K251302: OptiMesh Multiplanar Expandable Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Dec 15, 2025 after 231 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: 26 generations back to K841189 (1984). 310 ancestors in all.
No later device cites it as a predicate yet.
1 of 311 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230927: OptiMesh Multiplanar Expandable Interbody Fusion System, Spineology, Inc. (2023) Summary page 5.

## 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 I 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, along with a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion, is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

Source page: https://510kreport.com/device/K251302
Methodology: https://510kreport.com/methodology