Cleared Special

K133224 - Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES

K133224 is an FDA 510(k) clearance for Y-KNOT RC ALL-SUTURE ANCHOR, manufactured by Conmed Corporation. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 74-day FDA review.

K133224 · Conmed Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
74d
Days
Class 2
Risk

K133224 is an FDA 510(k) clearance for the Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HI.... 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 Conmed Corporation (Largo, US). The FDA issued a Cleared decision on January 3, 2014 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133224

510(k) Number K133224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2013
Decision Date January 03, 2014
Days to Decision 74 days
Submission Type Special
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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

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 602
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K133224.
GFS II STANDARD, GFS II LARGE, GFS MIMI
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TITANIUM SUTURE ANCHOR
K133229 · Mtp Solutions, LLC · Jan 2014
Q-FIX SUTURE ANCHOR, 1.8MM
K133727 · ArthroCare Corporation · Jan 2014
SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM
K132867 · Cayenne Medical, Inc. · Dec 2013
EXOSHAPE DUO SOFT TISSUE FASTENER
K132783 · MedShape, Inc. · Dec 2013
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
K130467 · MedShape, Inc. · Dec 2013