# K132310: ASCOT

- Pathway: 510(k) (Traditional)
- Applicant: Backroads Consulting, Inc.
- Decided: Dec 23, 2013 after 151 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: 9 generations back to K922087 (1992). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043082: The Tosca Anterior Cervical Plate System, Signus Medizintechnik GmbH (2004) Summary page 1.
- K080815: Tosca II Anterior Cervical Plate System, Signus Medizintechnik GmbH (2008)
- K051815: Modification to Vertebron SCP Cervical Plate System, Vertebron, Inc. (2005) Summary page 1.
- K062110: Vertebron SCP Cervical Plate System, Vertebron, Inc. (2006) Summary page 1.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 1.

## Indications for use
AsCorO is Intended for anterior cervical fixation (C2-C7) for the following Indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolistiiesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures 0.e., scollosis, kyphosis and/or lordosis). tumor, pseudarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K132310
Methodology: https://510kreport.com/methodology