Cleared Traditional

K111716 - KNOTLESS SUTURE FIXATION SYSTEM

K111716 is an FDA 510(k) clearance for KNOTLESS SUTURE FIXATION SYSTEM, manufactured by Core Essence Orthopaedics. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K111716 · Core Essence Orthopaedics · Orthopedic device
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Nov 2011
Decision
143d
Days
Class 2
Risk

K111716 is an FDA 510(k) clearance for the KNOTLESS SUTURE FIXATION 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 Core Essence Orthopaedics (Ft. Washington, US). The FDA issued a Cleared decision on November 10, 2011 after a review of 143 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 Core Essence Orthopaedics devices

FDA 510(k) Submission Details - K111716

510(k) Number K111716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date November 10, 2011
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
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 K111716.
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MODIFIED ROG SUTURE ANCHOR
K112991 · Rog Sports Medicine, Inc. · Dec 2011
LATERAL BUTTON
K112296 · T.A.G. Medical Products Corporation, Ltd. · Dec 2011
NANO SUTURE ANCHOR
K112965 · Linvatec Corporation D/B/A Conmed Linvatec · Nov 2011
META-LOCK SUTURE ANCHOR SYSTEM
K110800 · Tarsus Medical, Inc. · Sep 2011
BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
K110879 · Biomet Sports Medicine · Aug 2011