# K091134: Custom Spine Regent Anterior Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Custom Spine, Inc.
- Decided: Aug 17, 2009 after 119 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: 1 generation back to K030866 (2003). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041469: Anterior Compact System, X-Spine Systems (2004) Summary page 1.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K141993: Nakoma Acp (2014), 8 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K173128: Alamo® C (2018), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own

## Indications for use
The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: * Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Trauma (including fractures). * Tumors Deformities or curvatures (including kyphosis, lordosis or scoliosis) * Pseudoarthrosis * Failed previous fusion Spondylolisthesis Spinal Stenosis THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS. WARNING: THIS DEVICE 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/K091134
Methodology: https://510kreport.com/methodology