# K162638: CETRA Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Dec 16, 2016 after 85 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: 7 generations back to K922087 (1992). 33 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates, Blackstone Medical, Inc. (2010) Summary page 4.
- K030595: Blackstone Fusion Anterior Cervical Plating System, Blackstone Medical, Inc. (2003) Summary page 4.
- K013877: Codman Slim-Loc System, Codman & Shurtleff, Inc. (2001) Summary page 4.
- K133518: Maxan Anterior Cervical Plate System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 4.

## Most influential descendants
- K240935: ARENAL Anterior Cervical Plate System (2024), 0 descendants of its own
- K211712: 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System (2022), 0 descendants of its own
- K181190: Pinehurst Anterior Cervical Plate System (2019), 0 descendants of its own

## Indications for use
The CETRA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; c) Fracture; d) Spinal Stenosis; e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumor; g) Pseudoarthrosis; h) Revision of previous surgery

Source page: https://510kreport.com/device/K162638
Methodology: https://510kreport.com/methodology