# K052552: Hybrid Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Oct 13, 2005 after 27 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953730 (1995). 2 ancestors in all.
39 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013877: Codman Slim-Loc System, Codman & Shurtleff, Inc. (2001) Summary page 4.

## Most influential descendants
- K103491: Skyline Anterior Cervical Plate System (2011), 34 descendants of its own
- 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

## Recalls of this device
- Oct 12, 2016 · Class II · Z-0627-2017: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
- Oct 12, 2016 · Class II · Z-0628-2017: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
- Oct 12, 2016 · Class II · Z-0629-2017: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
- Oct 12, 2016 · Class II · Z-0626-2017: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
- Oct 12, 2016 · Class II · Z-0624-2017: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
- Oct 12, 2016 · Class II · Z-0625-2017: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
- Oct 12, 2016 · Class II · Z-0630-2017: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

## Indications for use
The Hybrid Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 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 pseudoarthosis 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/K052552
Methodology: https://510kreport.com/methodology