# K100805: Gallery Laminoplasty Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Jul 20, 2010 after 120 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: 4 generations back to K761228 (1976). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 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 1.
- K043338: Blakstone Laminoplasty Fixation System, Blackstone Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K232471: Vy Spine™ VyLam™ Laminoplasty System (2023), 1 descendant of its own
- K242784: Vy Spine™ VyLam™ Laminoplasty System (2024), 0 descendants of its own
- K202309: Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System (2020), 0 descendants of its own

## Indications for use
The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery Lamninoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

Source page: https://510kreport.com/device/K100805
Methodology: https://510kreport.com/methodology