# K191408: Nexxt Matrixx System

- Pathway: 510(k) (Special)
- Applicant: Nexxt Spine, LLC
- Decided: Jul 10, 2019 after 43 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: 22 generations back to K841189 (1984). 261 ancestors in all.
No later device cites it as a predicate yet.
1 of 262 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171140: Matrixx System, Nexxt Spine, LLC (2017) Summary page 4.
- K172009: Cascadia Interbody System, K2m, Inc. (2017) Summary page 4.

## Indications for use
When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.

Source page: https://510kreport.com/device/K191408
Methodology: https://510kreport.com/methodology