# K210155: Duo Expandable Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: Feb 19, 2021 after 29 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 25 generations back to K841189 (1984). 433 ancestors in all.
No later device cites it as a predicate yet.
1 of 434 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190055: Duo Lumbar Interbody Fusion Device, Spineology, Inc. (2019) Summary page 4.
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 4.

## Indications for use
The Duo™ Expandable Interbody Fusion System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K210155
Methodology: https://510kreport.com/methodology