# K083562: Stryker Spine Nulock Anterior Cervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Mar 25, 2009 after 113 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.
16 later devices descend from it; 3 cite it directly.
0 of 21 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
- K142237: Aviator Anterior Cervical Plate (ACP) System (2015), 9 descendants of its own
- K190227: Boomerang™ Anterior Cervical Plate System (2019), 4 descendants of its own
- K150759: Hyper-C Anterior Cervical Plate System (2015), 4 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own

## Indications for use
The Stryker Spine Aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator Anterior Cervical Plating 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 WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K083562
Methodology: https://510kreport.com/methodology