# K131025: Archon Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Nov 27, 2013 after 229 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- 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: 4 generations back to K922087 (1992). 17 ancestors in all.
97 later devices descend from it; 3 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122910: Archon Anterior Cervical Plate Syste,, Nu Vasive, Incorporated (2012) Summary page 2.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 1.
- K010003: Ebi Vuelock Anterior Cervical Plate System, Ebi, L.P. (2001)
- K053581: Nuvasive Smartplate Gradient Plus System, Nuvasive, Inc. (2006) Summary page 1.

## Most influential descendants
- K161442: NuVasive® CoRoent® Small Interlock™ System (2016), 94 descendants of its own
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (2017), 83 descendants of its own
- K180909: REVEL Spacers (2018), 37 descendants of its own
- K191243: HEDRON Cervical Spacers (2019), 36 descendants of its own
- K200087: F3D Cervical Stand-Alone Interbody Fusion System (2020), 25 descendants of its own

## Indications for use
The NuVasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of the implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. Additionally, the three-hole version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomnies for the treatment of tumors and burst fractures. WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K131025
Methodology: https://510kreport.com/methodology