# K150759: Hyper-C Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Degen Medical
- Decided: Jul 28, 2015 after 127 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 K000536 (2000). 6 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142237: Aviator Anterior Cervical Plate (ACP) System, Stryker Corporation (2015) Summary page 4.

## Most influential descendants
- K191786: Cyclops™ Anterior Cervical Plate System (2019), 1 descendant of its own
- K213901: Cyclops™ Anterior Cervical Plate System (2022), 0 descendants of its own
- K181549: Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) (2018), 0 descendants of its own
- K181562: Curiteva Anterior Cervical Plate System (2018), 0 descendants of its own

## Indications for use
The DeGen Medical Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications: • Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) • Spinal Stenosis • Trauma (i.e. fracture or dislocation) • Deformity or curvatures (including scoliosis, kyphosis, or lordosis) • Spinal Tumors • Pseudoarthrosis or failed previous fusion • Spondylolisthesis • Decompression of the spine following total or partial cervical vertebrectomy

Source page: https://510kreport.com/device/K150759
Methodology: https://510kreport.com/methodology