# K103491: Skyline Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: A Johnson & Johnson Company
- Decided: Feb 14, 2011 after 80 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: 3 generations back to K953730 (1995). 3 ancestors in all.
34 later devices descend from it; 14 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052552: Hybrid Anterior Cervical Plate System, Depuy Spine, Inc. (2005) Summary page 1.

## Most influential descendants
- K181244: Zavation Cervical Plate System (2018), 7 descendants of its own
- K221049: Zavation VariSync Plate System and VariSync Spacer System (2022), 6 descendants of its own
- K153526: Pyrenees Cervical Plate System (2016), 6 descendants of its own
- K172104: Ozark (tm) Cervical Plate System (2017), 5 descendants of its own
- K162664: Pyrenees Cervical Plate System (2016), 5 descendants of its own

## Indications for use
The SKYLINE® Anterior Cervical Plate System is indicated for stabilization of the cervical spine from 02 to 07 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: Instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudloarthorosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myleopathy.

Source page: https://510kreport.com/device/K103491
Methodology: https://510kreport.com/methodology