# K073708: Fixed, Variable & Corpectomy Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Precision Surgery, Ltd.
- Decided: Jun 3, 2008 after 155 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 3 (0 Class I)
- 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 its predicate without a number.
- (no number) Fixed & Variable Cervical Plate System: named in the summary without a submission 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

## Recalls of this device
- Mar 22, 2012 · Not classified · Z-1545-2012: Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical Plate System. The pre vacuum sterilization cycle [270 (132 C) for 3 minutes] has not been vali
- Nov 22, 2011 · Not classified · Z-1649-2012: Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instr
- Nov 22, 2011 · Not classified · Z-1648-2012: Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instr

## Indications for use
The Precision Surgery-Limited Fixed, Variable and Corpectomy 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 Fixed, Variable and Corpectomy 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/K073708
Methodology: https://510kreport.com/methodology