Cleared Traditional

K122336 - Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM

K122336 is an FDA 510(k) clearance for Q-FIX SUTURE ANCHOR, manufactured by Eleven Blade Solutions, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K122336 · Eleven Blade Solutions, Inc. · Orthopedic device
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Jan 2013
Decision
160d
Days
Class 2
Risk

K122336 is an FDA 510(k) clearance for the Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL.... 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 Eleven Blade Solutions, Inc. (Los Gatos, US). The FDA issued a Cleared decision on January 9, 2013 after a review of 160 days - an extended review cycle.

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 Eleven Blade Solutions, Inc. devices

FDA 510(k) Submission Details - K122336

510(k) Number K122336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2012
Decision Date January 09, 2013
Days to Decision 160 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
38d slower than avg
Panel avg: 122d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

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 564
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