# K260697: VyPlate™ Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Vy Spine, LLC
- Decided: Mar 27, 2026 after 23 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: 10 generations back to K922087 (1992). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221572: VyPlate Anterior Cervical Plate System, Vy Spine, LLC (2022) Summary page 5.

## Indications for use
The VyPlate™ Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: • instability caused by trauma or fracture; • instability associated with correction of cervical lordosis and kyphosis deformity; • instability associated with pseudoarthosis as a result of previously failed cervical spine surgery; • instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; • instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy. This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K260697
Methodology: https://510kreport.com/methodology