# K153735: Release Laminoplasty Fixation System

- Pathway: 510(k) (Special)
- Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
- Decided: Jan 21, 2016 after 24 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113218: Pioneer Release Laminoplasty Plating System, Pioneer Surgical Technology, Inc. (2012) Summary page 4.
- K091994: Mountaineer Laminoplasty System, Depuy Spine, Inc. (2010) Summary page 4.

## Indications for use
The Release® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Release® Laminoplasty Fixation 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/K153735
Methodology: https://510kreport.com/methodology