# K063430: Zero Profile Anterior Cervical Plate (Acp) System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Mar 22, 2007 after 129 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 K000536 (2000). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062310: Reflex Hybrid Acp System, Stryker Spine (2006) Summary page 1.
- K040261: Reflex Hybrid Anterior Cervical Plate System, Stryker Spine (2004) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.

## Most influential descendants
- K221728: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate (2022), 1 descendant of its own
- K230424: Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System (2023), 0 descendants of its own

## Indications for use
The Zero Profile Anterior Cervical Plating (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-TI. 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 patient history and radiographic studies) * Trauma (including fractures) * Tumors * Deformities or curvatures (including kyphosis, lordosis, or scoliosis) * Pseudarthrosis * Failed previous fusion * Decompression of the spinal cord following total or partial cervical vertebrectomy * Spondylolisthesis * Spinal stenosis WARNING: This device is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K063430
Methodology: https://510kreport.com/methodology