# K121732: Canopy Laminoplasty Fixation System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Oct 31, 2012 after 140 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). 15 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080664: Relieve Laminoplasty Fixation System, Globus Medical, Inc. (2008) Summary page 1.
- K050082: Centerpiece Plate Fixation System, Medtronic Sofamor Danek, Inc. (2005) Summary page 1.
- K091994: Mountaineer Laminoplasty System, Depuy Spine, Inc. (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K032534: Synthes Afs, Synthes Spine (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K171413: HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (2017), 6 descendants of its own
- K180156: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System (2018), 5 descendants of its own
- K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System (2018), 4 descendants of its own
- K231232: Curiteva Laminoplasty System (2023), 2 descendants of its own
- K191584: FORTICO Anterior Cervical Fixation System (2019), 2 descendants of its own

## Indications for use
The CANOPY TM Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY Tm Laminoplasty Fixation System is used to hold bone allograft material in place in order to prevent the allograft from expulsion or impinging the spinal cord.

Source page: https://510kreport.com/device/K121732
Methodology: https://510kreport.com/methodology