Cleared Traditional

K173215 - Choice Spine Laminoplasty™ Fixation System

K173215 is an FDA 510(k) clearance for Choice Spine Laminoplasty Fixation System, manufactured by Choicespine, LP. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K173215 · Choicespine, LP · Orthopedic device
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Jan 2018
Decision
109d
Days
Class 2
Risk

K173215 is an FDA 510(k) clearance for the Choice Spine Laminoplasty™ Fixation System. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Choicespine, LP (Knoxville, US). The FDA issued a Cleared decision on January 19, 2018 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Choicespine, LP devices

FDA 510(k) Submission Details - K173215

510(k) Number K173215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date January 19, 2018
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
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 27
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K173215.
Hinged Laminoplasty System
K191927 · Life Spine, Inc. · Sep 2019
NuVasive® Camber Laminoplasty System
K191169 · Nu Vasive, Incorporated · Jul 2019
Life Spine Laminoplasty System
K181717 · Life Spine, Inc. · Oct 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