# K113218: Pioneer Release Laminoplasty Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Jan 26, 2012 after 86 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). 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)
- K091994: Mountaineer Laminoplasty System, Depuy Spine, Inc. (2010) Summary page 1.
- K050082: Centerpiece Plate Fixation System, Medtronic Sofamor Danek, Inc. (2005) Summary page 1.

## Most influential descendants
- K153735: Release Laminoplasty Fixation System (2016), 0 descendants of its own

## Indications for use
The Pioneer Release Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Pioneer Release Laminoplasty Plating System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

Source page: https://510kreport.com/device/K113218
Methodology: https://510kreport.com/methodology