# K193412: NEXXT MATRIXX System

- Pathway: 510(k) (Traditional)
- Applicant: Nexxt Spine, LLC
- Decided: Feb 24, 2020 after 77 days
- Product code: PLR (Spinal Vertebral Body Replacement Device - Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K841189 (1984). 256 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 258 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 5.
- K120345: Honour Spacer System, Nexxt Spine, LLC (2012) Summary page 5.
- K180665: SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System, K2m, LLC (2018) Summary page 5.

## Most influential descendants
- K232481: RIGEL™ 3DR Anterior Cervical Corpectomy System (2023), 0 descendants of its own

## Indications for use
The NEXXT MATRIXX® corpectomy devices are indicated for use in the cervical spine (C2-T1) and thoracolumbar spine (T1-L5) in skeletally mature patients to replace a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The NEXXT MATRIXX® corpectomy devices are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. The NEXXT MATRIXX® corpectomy devices are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion and with FDA-cleared supplemental internal fixation.

Source page: https://510kreport.com/device/K193412
Methodology: https://510kreport.com/methodology