Cleared Special

K173550 - Akros FibuLink Syndesmosis Repair Kit

K173550 is the FDA 510(k) clearance for Akros FibuLink Syndesmosis Repair Kit by Akros Medical. It is a Class 2 Orthopedic device (product code HTN) cleared through the Special 510(k) pathway after a 28-day FDA review.

K173550 · Akros Medical · Orthopedic device
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Dec 2017
Decision
28d
Days
Class 2
Risk

K173550 is an FDA 510(k) clearance for the Akros FibuLink™ Syndesmosis Repair Kit. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Akros Medical (Durham, US). The FDA issued a Cleared decision on December 14, 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 888.3030 - 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 Akros Medical devices

Submission Details

510(k) Number K173550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2017
Decision Date December 14, 2017
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HTN Washer, Bolt Nut
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 - HTN Washer, Bolt Nut

All 66
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