# K190055: Duo Lumbar Interbody Fusion Device

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: Mar 7, 2019 after 55 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: 16 generations back to K841189 (1984). 104 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182322: Duo Lumbar Interbody Fusion Device, Spineology, Inc. (2018) Summary page 4.
- K181792: Duo™ Lumbar Interbody Fusion Device, Spineology, Inc. (2018) Summary page 4.
- K123767: Lanx Fusion System- SA, Lanx, Inc. (2013) Summary page 4.

## Most influential descendants
- K210155: Duo Expandable Interbody Fusion System (2021), 0 descendants of its own

## Indications for use
The Duo™ Lumbar Interbody Fusion Device 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/K190055
Methodology: https://510kreport.com/methodology