# K230927: OptiMesh Multiplanar Expandable Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Nov 1, 2023 after 212 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: 25 generations back to K841189 (1984). 309 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 311 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 5.

## Most influential descendants
- K251302: OptiMesh Multiplanar Expandable Interbody Fusion System (2025), 0 descendants of its own

## 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 with compatible allograft and autograft, or 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. AFT is intended for use as a bone void filler in the extremities, spine, intervertebral disc space, and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury. When used in intervertebral body fusion procedures, AFT must be used on its own with an intervertebral body graft containment device cleared by FDA for use with a bone void filler. AFT is intended for single patient use only.

Source page: https://510kreport.com/device/K230927
Methodology: https://510kreport.com/methodology