# K152239: Zero-P Natural Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa), LLC
- Decided: Dec 2, 2015 after 114 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 K031276 (2003). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141500: Optio-C Anterior Cervical System, Zimmer Spine, Inc. (2014) Summary page 4.
- K071667: Synthes Vectra-One System, Synthes Spine (2007) Summary page 4.

## Indications for use
The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The plate and four screw system has been designed designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of this plate system include degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthosis or failed previous fusion. The plate is intended for one level in the cervical spine, from C2 to T1.

Source page: https://510kreport.com/device/K152239
Methodology: https://510kreport.com/methodology