# K232471: Vy Spine™ VyLam™ Laminoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Vy Spine, LLC
- Decided: Oct 10, 2023 after 55 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: 5 generations back to K761228 (1976). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032534: Synthes Afs, Synthes Spine (2004) Summary page 4.
- K100805: Gallery Laminoplasty Fixation System, Biomet Spine (Aka Ebi, LLC) (2010) Summary page 4.

## Most influential descendants
- K242784: Vy Spine™ VyLam™ Laminoplasty System (2024), 0 descendants of its own

## 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/K232471
Methodology: https://510kreport.com/methodology