# K103838: Fixed Variable & Corpectomy Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Surgery, Ltd.
- Decided: Feb 15, 2011 after 47 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: 1 generation back to K032815 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032815: Precision Surgery Limited Variable and Fixed Cervical Plate System, Precision Surgery Limited (2004) Summary page 1.
- K073708: Fixed, Variable & Corpectomy Cervical Plate System, Precision Surgery, Ltd. (2008) Summary page 1.

## Indications for use
The Intuitive Anterior Cervical System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. WARNING: The Intuitive Anterior Cervical System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K103838
Methodology: https://510kreport.com/methodology