# K223852: VySpan™ PCT System

- Pathway: 510(k) (Special)
- Applicant: Vy Spine, LLC
- Decided: Feb 24, 2023 after 64 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K853033 (1985). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213394: Vy Spine™ VySpan™ PCT System, Vy Spine, LLC (2021) Summary page 4.

## Most influential descendants
- K232167: VySpan™ PCT System (2023), 0 descendants of its own

## Indications for use
The VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), and is indicated for the following: • ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) • Spondylolisthesis • Spinal stenosis • Fracture/dislocation • Revision of previous cervical spine surgery • Tumors The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Hooks and Rods The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-to-rod connectors.

Source page: https://510kreport.com/device/K223852
Methodology: https://510kreport.com/methodology