# K181397: DualX

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive, Inc.
- Decided: Sep 27, 2018 after 121 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: 19 generations back to K841189 (1984). 309 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 325 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123281: Acculif TL-Peek Cage, Coalign Innovations, Inc. (2013) Summary page 7.
- K152651: AccuLIF TL and PL Cage, Stryker Corporation (2015) Summary page 7.
- K120966: Depuy Pulse Lumbar Cage System, Medos International SARL (2012) Summary page 7.
- K171519: FLXfit™, Expanding Orthopedics, Inc. (2017) Summary page 7.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016) Summary page 7.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 7.

## Most influential descendants
- K203038: Toro-L Interbody Fusion System (2021), 5 descendants of its own
- K213355: Toro-L Interbody Fusion System (2022), 4 descendants of its own
- K222203: DualXSLIM (R) T/PLIF (2022), 3 descendants of its own
- K221894: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants (2023), 2 descendants of its own
- K231275: Exceed™ Biplanar Expandable Interbody System (2023), 2 descendants of its own

## Indications for use
The DualX™ PLIF is 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. The DualX™ PLIF is indicated for unilateral or Bilateral implantation. The DualX™ LLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to L5, 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. The DualX™ TLIF is 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/K181397
Methodology: https://510kreport.com/methodology