# K032815: Precision Surgery Limited Variable and Fixed Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Surgery Limited
- Decided: Feb 12, 2004 after 156 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K141332: Captiva Spine SmartLOX Cervical Plate System (2015), 1 descendant of its own
- K200301: UNiTi ACDF Implant System (2021), 0 descendants of its own
- K103819: PSL Anterior Cervical Plate System (2011), 0 descendants of its own
- K103838: Fixed Variable & Corpectomy Cervical Plate System (2011), 0 descendants of its own

## Indications for use
The Precision Surgery Limited Variable and Fixed Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include 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 Precision Surgery Limited Variable and Fixed Cervical Plate 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/K032815
Methodology: https://510kreport.com/methodology