Cleared Traditional

K131325 - QUATTRO GL SUTURE ANCHOR

K131325 is the FDA 510(k) clearance for QUATTRO GL SUTURE ANCHOR by Cayenne Medical, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K131325 · Cayenne Medical, Inc. · Orthopedic device
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Aug 2013
Decision
100d
Days
Class 2
Risk

K131325 is an FDA 510(k) clearance for the QUATTRO GL SUTURE ANCHOR. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Cayenne Medical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on August 16, 2013 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Cayenne Medical, Inc. devices

Submission Details

510(k) Number K131325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2013
Decision Date August 16, 2013
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K131325.
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
K132513 · ArthroCare Corporation · Sep 2013
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132632 · Tornier, Inc. · Sep 2013
5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
K132590 · ArthroCare Corporation · Sep 2013
TOGGLELOC XTENDER
K130033 · Biomet Manufacturing Corp · Aug 2013
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
K130814 · Depuy Mitek, A Johnson & Johnson Company · Aug 2013
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
K130217 · OrthoPediatrics Corp. · Jun 2013