Cleared Traditional

K131182 - MULTIFIX S KNOTLESS FIXATION DEVICE

K131182 is an FDA 510(k) clearance for MULTIFIX S KNOTLESS FIXATION DEVICE, manufactured by Arthocare Corporation. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K131182 · Arthocare Corporation · Orthopedic device
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Jul 2013
Decision
94d
Days
Class 2
Risk

K131182 is an FDA 510(k) clearance for the MULTIFIX S KNOTLESS FIXATION DEVICE. 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 Arthocare Corporation (Austin, US). The FDA issued a Cleared decision on July 29, 2013 after a review of 94 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 Arthocare Corporation devices

FDA 510(k) Submission Details - K131182

510(k) Number K131182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2013
Decision Date July 29, 2013
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K131182.
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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
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K131683 · Depuy Mitek, Inc., A Johnson and Johnson Company · Jun 2013
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K130217 · OrthoPediatrics Corp. · Jun 2013