Cleared Special

K170098 - ICONIX TT All Suture Anchor

K170098 is the FDA 510(k) clearance for ICONIX TT All Suture Anchor by Stryker. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 79-day FDA review.

K170098 · Stryker · Orthopedic device
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Mar 2017
Decision
79d
Days
Class 2
Risk

K170098 is an FDA 510(k) clearance for the ICONIX TT All 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 Stryker (Greenwood Village, US). The FDA issued a Cleared decision on March 31, 2017 after a review of 79 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.

View all Stryker devices

Submission Details

510(k) Number K170098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2017
Decision Date March 31, 2017
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

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 416
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K170098.
Stryker Self-Punching ICONIX
K171465 · Stryker · Aug 2017
Q-Fix Suture Anchor
K172165 · ArthroCare Corporation · Aug 2017
Arthrex Knotless SutureTak Anchor
K171020 · Arthrex, Inc. · May 2017
GRAVITYTM PEEK-OPTIMA Suture Anchor
K170265 · Wrightmedicaltechnologyinc · Feb 2017
CrossFT Knotless Suture Anchor with Disposable Driver
K163258 · Conmed Corporation · Jan 2017
MILAGRO ADVANCE PEEK Interference Screw
K161001 · Medos International SARL · Jun 2016