Cleared Traditional

K113297 - KNOTILUS ANCHOR SYSTEM

K113297 is an FDA 510(k) clearance for KNOTILUS ANCHOR SYSTEM, manufactured by T.A.G. Medical Products Corporation, Ltd.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K113297 · T.A.G. Medical Products Corporation, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
115d
Days
Class 2
Risk

K113297 is an FDA 510(k) clearance for the KNOTILUS ANCHOR SYSTEM. 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 T.A.G. Medical Products Corporation, Ltd. (Somerset, US). The FDA issued a Cleared decision on March 2, 2012 after a review of 115 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 T.A.G. Medical Products Corporation, Ltd. devices

FDA 510(k) Submission Details - K113297

510(k) Number K113297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2011
Decision Date March 02, 2012
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 451
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K113297.
PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
K120942 · Parcus Medical, LLC · Apr 2012
MULTIFIX P KNOTLESS FIXATION DEVICE
K120096 · ArthroCare Corporation · Mar 2012
FOOTPRINT ULTRA PK SUTURE ANCHOR
K113274 · Smith & Nephew, Inc. · Mar 2012
ARTHREX KNOTLESS SUTURETAK ANCHOR
K120155 · Arthrex, Inc. · Feb 2012
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
K112526 · Smith & Nephew, Inc. · Jan 2012
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
K113294 · Smith & Nephew, Inc. · Jan 2012