Cleared Traditional

K113218 - PIONEER RELEASE LAMINOPLASTY PLATING SY...

K113218 is the FDA 510(k) clearance for PIONEER RELEASE LAMINOPLASTY PLATING SY... by Pioneer Surgical Technology, Inc.. It is a Class 2 Orthopedic device (product code NQW) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K113218 · Pioneer Surgical Technology, Inc. · Orthopedic device
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Jan 2012
Decision
86d
Days
Class 2
Risk

K113218 is an FDA 510(k) clearance for the PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on January 26, 2012 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pioneer Surgical Technology, Inc. devices

Submission Details

510(k) Number K113218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2011
Decision Date January 26, 2012
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K113218.
Xspan Laminoplasty Fixation System
K160114 · X-Spine Systems, Inc. · Mar 2016
CANOPY LAMINOPLASTY FIXATION SYSTEM
K121732 · Globus Medical, Inc. · Oct 2012
ESCALATE LAMINOPLASTY SYSTEM
K113802 · Stryker Spine · Apr 2012
MOUNTAINEER LAMINOPLASTY SYSTEM
K091994 · Depuy Spine, Inc. · Jan 2010
LAMINOPLASTY FIXATION SYSTEM
K091623 · Nuvasive, Inc. · Oct 2009
RELIEVE LAMINOPLASTY FIXATION SYSTEM
K080664 · Globus Medical, Inc. · Jul 2008