# K190546: NEXXT MATRIXX Stand Alone Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Nexxt Spine, LLC
- Decided: May 31, 2019 after 87 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 21 generations back to K841189 (1984). 315 ancestors in all.
93 later devices descend from it; 4 cite it directly.
1 of 409 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181837: Spinal Elements Ti-Bond coated devices, Spinal Elements, Inc. (2018) Summary page 4.
- K132029: Vault-C Intervertebral Body Fusion Device, Spinal USA (2013) Summary page 5.
- K171140: Matrixx System, Nexxt Spine, LLC (2017) Summary page 5.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 5.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 5.
- K120345: Honour Spacer System, Nexxt Spine, LLC (2012) Summary page 5.
- K052292: Spider Cervical Plating (SCP) System, X-Spine Systems, Inc. (2005) Summary page 5.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 5.

## Most influential descendants
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), 72 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own

## Indications for use
The NEXXT MATRIXX® Stand Alone Cervical System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical System is intended to be used with the bone screw fixation provided and requires no additional fixation.

Source page: https://510kreport.com/device/K190546
Methodology: https://510kreport.com/methodology