# K091994: Mountaineer Laminoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Jan 7, 2010 after 189 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: 3 generations back to K761228 (1976). 12 ancestors in all.
17 later devices descend from it; 7 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050082: Centerpiece Plate Fixation System, Medtronic Sofamor Danek, Inc. (2005) Summary page 1.
- K032534: Synthes Afs, Synthes Spine (2004) Summary page 1.

## Most influential descendants
- K121732: Canopy Laminoplasty Fixation System (2012), 10 descendants of its own
- 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
- K173215: Choice Spine Laminoplasty™ Fixation System (2018), 4 descendants of its own

## Indications for use
The MOUNTAINEER® Laminoplasty Systein is intended for use in the lower cervical and upper thoracic spine (C3 1o T3) in laminoplasty procedures. The MOQUNTAINEER Laminoplasty System is used to hokd or buliress the allograft or autograft material in place in erder to prevent the allografl or autograft material from expulsion of impinging the spinai cord.

Source page: https://510kreport.com/device/K091994
Methodology: https://510kreport.com/methodology