# K101151: Regent Anterior Cervical Plate

- Pathway: 510(k) (Special)
- Applicant: Custom Spine
- Decided: May 19, 2010 after 26 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: 2 generations back to K030866 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091134: Custom Spine Regent Anterior Cervical Plate, Custom Spine, Inc. (2009) Summary page 1.

## 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 kylphosis, lordlosi s or scoliosis) Pseudloarthrosis Failed previous fusion Spondylolisthesis Spinal Stenosis THIS DEVICE ISONLY TO BE USED IN SKELETALLY MATURE PATIENTS. WARNING: THIS DEVICE ISNOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

Source page: https://510kreport.com/device/K101151
Methodology: https://510kreport.com/methodology