Cleared Traditional

K162805 - Akros Fibulink Syndesmosis Repair Kit

K162805 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 Traditional 510(k) pathway after a 97-day FDA review.

K162805 · Akros Medical · Orthopedic device
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Jan 2017
Decision
97d
Days
Class 2
Risk

K162805 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 January 10, 2017 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Akros Medical devices

Submission Details

510(k) Number K162805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2016
Decision Date January 10, 2017
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K162805.
PUMA System
K171703 · Panther Orthopedics, Inc. · Mar 2018
GRAVITY™ Syndesmosis LP
K170249 · Wrightmedicaltechnologyinc · Jun 2017
INVISIKNOT Ankle Syndesmosis Repair Kit
K162996 · Smith & Nephew, Inc. · Jun 2017
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
K141219 · Biomet Manufacturing Corp · Jul 2014
CMC MINI TIGHTROPE
K140328 · Arthrex, Inc. · Mar 2014
MINI TIGHTROPE
K133275 · Arthrex, Inc. · Jan 2014