# DEN200010: Spineology Interbody Fusion System

- Pathway: De Novo (Direct)
- Applicant: Spineology, Inc.
- Decided: Sep 18, 2020 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K231781: OptiMesh Multiplanar Expandable Interbody Fusion System (2023), 0 descendants of its own

## Indications for use
The Spineology Interbody Fusion System (SIFS) 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 1 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. SIFS 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/DEN200010
Methodology: https://510kreport.com/methodology