# K132324: Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System, Uniplate 2 Anterior Cervical Plate Syst

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Sep 6, 2013 after 42 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: 4 generations back to K971730 (1997). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 13 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.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 1.
- K082273: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 3.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 1.

## Most influential descendants
- K191584: FORTICO Anterior Cervical Fixation System (2019), 2 descendants of its own
- K232256: Alcantara Thoracolumbar Plate System (2024), 0 descendants of its own
- K211205: Prase-C Anterior Cervical Plate System (2021), 0 descendants of its own

## Indications for use
The SKYLINE Anterior Cervical Plate System isindicated 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 lordaosis and kyphosis deformity; instability associated with pseudloarthrosis 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 myelopathy. The UNIPLATE Anterior Cervical Plate System and UINIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are Indicated for patients in which stability isdesired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to Ti. Indications Include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or Instability following surgery for the above indications. The UNIPLATE and UNIPLATE 2Anterior Cervical Plate Systems are also indicated for treatment of spinal stenosis.

Source page: https://510kreport.com/device/K132324
Methodology: https://510kreport.com/methodology