Cleared Traditional

K170440 - KISSloc Suture System

K170440 is an FDA 510(k) clearance for KISSloc Suture System, manufactured by Arthrosurface, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K170440 · Arthrosurface, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
78d
Days
Class 2
Risk

K170440 is an FDA 510(k) clearance for the KISSloc Suture System. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on May 3, 2017 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrosurface, Inc. devices

FDA 510(k) Submission Details - K170440

510(k) Number K170440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2017
Decision Date May 03, 2017
Days to Decision 78 days
Submission Type Traditional
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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K170440.
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K141219 · Biomet Manufacturing Corp · Jul 2014
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
K133835 · Arthrosurface, Inc. · Jul 2014
CMC MINI TIGHTROPE
K140328 · Arthrex, Inc. · Mar 2014