Cleared Special

K180662 - Arthrex FastThread Interference Screw

K180662 is the FDA 510(k) clearance for Arthrex FastThread Interference Screw by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Special 510(k) pathway after a 69-day FDA review.

K180662 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
69d
Days
Class 2
Risk

K180662 is an FDA 510(k) clearance for the Arthrex FastThread Interference Screw. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 22, 2018 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Arthrex, Inc. devices

Submission Details

510(k) Number K180662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date May 22, 2018
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

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