# K160702: ZION Anterior Cervical Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: Aug 23, 2016 after 162 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: 5 generations back to K953730 (1995). 26 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132012: Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate System, Zimmer Spine, Inc. (2013) Summary page 4.
- K060025: Slimplicity Anterior Cervical Plate System, Spinal USA (2006) Summary page 4.
- K080646: C-Tek Maxan Anterior Cervical Plate System, Biomet Spine (2008) Summary page 4.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 4.
- K082273: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 4.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 4.

## Most influential descendants
- K250446: Frida™ Anterior Cervical Plate System (2025), 0 descendants of its own
- K213456: Xenco Medical Multilevel CerviKit (2021), 0 descendants of its own
- K192494: NexGen Anterior Cervical Plate System (2019), 0 descendants of its own

## Indications for use
The ZION Anterior Cervical Fixation System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

Source page: https://510kreport.com/device/K160702
Methodology: https://510kreport.com/methodology