Cleared Special

K170530 - Butrex Lumbar Buttress Plating System

K170530 is an FDA 510(k) clearance for Butrex Lumbar Buttress Plating System, manufactured by X-Spine Systems, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 28-day FDA review.

K170530 · X-Spine Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
28d
Days
Class 2
Risk

K170530 is an FDA 510(k) clearance for the Butrex Lumbar Buttress Plating System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on March 22, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 - K170530

510(k) Number K170530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2017
Decision Date March 22, 2017
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 667
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K170530.
Cure™ Lumbar Plate System
K171538 · Meditech Spine, LLC · Jun 2017
Trifore(tm) Cervical Plating System
K171112 · Neurostructures, Inc. · Jun 2017
Ocata Anterior Cervical System
K170342 · Kalitec Direct, LLC · May 2017
Z-Span Plate System
K162824 · Zavation, LLC · Feb 2017
Kepler I Cervical Plate System
K163602 · Orbbo Surgical, LLC · Feb 2017
Altus Spine Cervical Plate System
K163061 · Altus Partners, LLC · Feb 2017
K170530 · Butrex Lumbar Buttress Plating System
Download PDF FDA Summary X-Spine Systems, Inc.