# K202230: NEXXT MATRIXX Stand Alone ALIF System

- Pathway: 510(k) (Traditional)
- Applicant: Nexxt Spine, LLC
- Decided: Dec 15, 2020 after 130 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182139: AXTi Titanium Stand-Alone ALIF System, Innovasis, Inc. (2019) Summary page 4.

## Indications for use
The NEXXT MATRIXX® Stand Alone ALIF System is a stand-alone anterior lumbar interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (L2-S1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels and should have received at least six months of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone ALIF System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation). Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation.

Source page: https://510kreport.com/device/K202230
Methodology: https://510kreport.com/methodology