# K171140: Matrixx System

- Pathway: 510(k) (Traditional)
- Applicant: Nexxt Spine, LLC
- Decided: Aug 22, 2017 after 126 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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). 217 ancestors in all.
145 later devices descend from it; 14 cite it directly.
1 of 363 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160125: Cascadia Interbody System, K2m (2016) Summary page 6.
- K120345: Honour Spacer System, Nexxt Spine, LLC (2012) Summary page 6.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 6.

## Most influential descendants
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K190546: NEXXT MATRIXX Stand Alone Cervical System (2019), 93 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), 72 descendants of its own

## Indications for use
When used as a cervical intervertebral fusion device, the Matrixx™ System open devices are indicated for use at up to two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation. When used as a lumbar intervertebral fusion device, the Matrixx™ System 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 Matrixx™ System 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. When used as a vertebral body replacement device, the Matrixx™ System open and solid devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation.

Source page: https://510kreport.com/device/K171140
Methodology: https://510kreport.com/methodology