Cleared Traditional

K181680 - ICONN Answer II Suture Anchor

K181680 is the FDA 510(k) clearance for ICONN Answer II Suture Anchor by Iconn Orthopedics, LLC. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K181680 · Iconn Orthopedics, LLC · Orthopedic device
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Aug 2018
Decision
44d
Days
Class 2
Risk

K181680 is an FDA 510(k) clearance for the ICONN Answer II Suture Anchor. 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 Iconn Orthopedics, LLC (Birmingham, US). The FDA issued a Cleared decision on August 9, 2018 after a review of 44 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iconn Orthopedics, LLC devices

Submission Details

510(k) Number K181680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2018
Decision Date August 09, 2018
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 390
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K181680.
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K181083 · Stryker · Jul 2018
AEVUMED PHANTOM Suture Anchors
K180464 · Aevumed, Inc. · May 2018