# K242784: Vy Spine™ VyLam™ Laminoplasty System

- Pathway: 510(k) (Special)
- Applicant: Vy Spine, LLC
- Decided: Oct 16, 2024 after 30 days
- Product code: NQW (Orthosis, Spine, Plate, Laminoplasty, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K761228 (1976). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232471: Vy Spine™ VyLam™ Laminoplasty System, Vy Spine, LLC (2023) Summary page 5.
- K050082: Centerpiece Plate Fixation System, Medtronic Sofamor Danek, Inc. (2005) Summary page 5.

## Indications for use
The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.

Source page: https://510kreport.com/device/K242784
Methodology: https://510kreport.com/methodology