# K042798: C-Tek C-Trun Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Nov 4, 2004 after 27 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 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
- K143576: Exactech Ambassador (2015), 7 descendants of its own
- K190227: Boomerang™ Anterior Cervical Plate System (2019), 4 descendants of its own
- K122216: Reliance Anterior Cervical Plate System (2012), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K140742: Reliance Anterior Cervical Plate (2014), 2 descendants of its own

## Indications for use
The INTERPORE CROSS C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C 7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

Source page: https://510kreport.com/device/K042798
Methodology: https://510kreport.com/methodology