Cleared Traditional

K160114 - Xspan Laminoplasty Fixation System

K160114 is an FDA 510(k) clearance for Xspan Laminoplasty Fixation System, manufactured by X-Spine Systems, Inc.. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K160114 · X-Spine Systems, Inc. · Orthopedic device
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Mar 2016
Decision
56d
Days
Class 2
Risk

K160114 is an FDA 510(k) clearance for the Xspan Laminoplasty Fixation System. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on March 15, 2016 after a review of 56 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 X-Spine Systems, Inc. devices

FDA 510(k) Submission Details - K160114

510(k) Number K160114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date March 15, 2016
Days to Decision 56 days
Submission Type Traditional
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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 28
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K160114.
Life Spine Laminoplasty System
K181717 · Life Spine, Inc. · Oct 2018
Choice Spine Laminoplasty™ Fixation System
K173215 · Choicespine, LP · Jan 2018
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413 · Globus Medical, Inc. · Jul 2017
Release Laminoplasty Fixation System
K153735 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jan 2016
Integra Laminoplasty System
K150469 · Seaspine, Inc. · Mar 2015
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
K132740 · Spinefrontier, Inc. · Nov 2013