# K112533: Zavation Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation, LLC
- Decided: Dec 8, 2011 after 101 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: 4 generations back to K971730 (1997). 9 ancestors in all.
26 later devices descend from it; 5 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993066: Window Cervical Dynamic Plate System, Advanced Spine Technology, Inc. (2000) Summary page 2.
- K070681: Next Generation Anterior Cervical Plating System, Alphatec Spine, Inc. (2007) Summary page 2.
- K013877: Codman Slim-Loc System, Codman & Shurtleff, Inc. (2001) Summary page 2.

## Most influential descendants
- K130030: Zavation Cervical Plate System (2013), 15 descendants of its own
- K181244: Zavation Cervical Plate System (2018), 7 descendants of its own
- K221049: Zavation VariSync Plate System and VariSync Spacer System (2022), 6 descendants of its own
- K172104: Ozark (tm) Cervical Plate System (2017), 5 descendants of its own
- K182473: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems (2018), 4 descendants of its own

## Indications for use
The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmied by history and radiographic studies), spondylohisthesis, traumna (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordlosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Source page: https://510kreport.com/device/K112533
Methodology: https://510kreport.com/methodology