Cleared Special

Barricaid Instrument Tray (K201676) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201676 · Intrinsic Therapeutics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
27d
Days
Class 2
Risk

K201676 is an FDA 510(k) clearance for the Barricaid Instrument Tray. Classified as Defect Measurement Tool (product code QHG), Class II - Special Controls.

Submitted by Intrinsic Therapeutics, Inc. (Woburn, US). The FDA issued a Cleared decision on July 16, 2020 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4510 - 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.

View all Intrinsic Therapeutics, Inc. devices

Submission Details

510(k) Number K201676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2020
Decision Date July 16, 2020
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QHG Defect Measurement Tool
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4510
Definition Manual Surgical Instrument For Appropriate Patient Select For Orthopedic Implant Is A Device Used To Measure An Anatomical Feature(s) To Determine Appropriate Patient Selection For An Orthopedic Implant. The Characteristics Of The Instrument Are Defined By The Specifications Set For Use Of The Orthopedic Implant In Terms Of Geometry, Surgical Technique, And Use Of The Device.
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.