Cleared Special

K153735 - Release Laminoplasty Fixation System

K153735 is an FDA 510(k) clearance for Release Laminoplasty Fixation System, manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The device is a Class 2 Orthopedic device with product code NQW cleared through the Special 510(k) pathway after a 24-day FDA review.

K153735 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
24d
Days
Class 2
Risk

K153735 is an FDA 510(k) clearance for the Release Laminoplasty Fixation System. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on January 21, 2016 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K153735

510(k) Number K153735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date January 21, 2016
Days to Decision 24 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

NQW Device Classification - Class 2, Special Controls

Product Code NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 29
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K153735.
Choice Spine Laminoplasty™ Fixation System
K173215 · Choicespine, LP · Jan 2018
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413 · Globus Medical, Inc. · Jul 2017
Xspan Laminoplasty Fixation System
K160114 · X-Spine Systems, Inc. · Mar 2016
Integra Laminoplasty System
K150469 · Seaspine, Inc. · Mar 2015
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
K132740 · Spinefrontier, Inc. · Nov 2013
INTEGRA LAMINOPLASTY SYSTEM
K130830 · Seaspine, Inc. · May 2013
K153735 · Release Laminoplasty Fixation System
Download PDF FDA Summary Pioneer Surgical Tech…