# K141332: Captiva Spine SmartLOX Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Captiva Spine
- Decided: Jun 11, 2015 after 386 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: 2 generations back to K792352 (1979). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 5.
- K073708: Fixed, Variable & Corpectomy Cervical Plate System, Precision Surgery, Ltd. (2008) Summary page 5.
- K042499: Orion Anterior Cervical Plating System, Medtronic Sofamor Danek (2004) Summary page 5.

## Most influential descendants
- K200301: UNiTi ACDF Implant System (2021), 0 descendants of its own

## Indications for use
The Captiva Spine SmartLOX 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, pseudoarthrosis or failed previous fusion. WARNING: The Captiva Spine SmartLOX 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/K141332
Methodology: https://510kreport.com/methodology