# K150700: ACP 1 Anterior Cervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Jul 15, 2015 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: 6 generations back to K953730 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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.
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K133518: Maxan Anterior Cervical Plate System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 4.

## Indications for use
The ACP 1™ Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The ACP 1™ 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 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

Source page: https://510kreport.com/device/K150700
Methodology: https://510kreport.com/methodology