# K211740: DualX

- Pathway: 510(k) (Special)
- Applicant: Amplify Surgical, Inc.
- Decided: Sep 29, 2021 after 114 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: 20 generations back to K841189 (1984). 314 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 316 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181397: DualX, Innovasive, Inc. (2018) Summary page 5.
- K142498: MAGNIFY and MAGNIFY-S Spacers, Globus Medical, Inc. (2015) Summary page 5.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 5.

## Most influential descendants
- K223335: SIRION Lateral Lumbar Interbody System (2023), 0 descendants of its own

## Indications for use
The DualX® ALIF and OLIF are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K211740
Methodology: https://510kreport.com/methodology