Cleared Special

Iconix Anchor (K233468) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233468 · Riverpoint Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
21d
Days
Class 2
Risk

K233468 is an FDA 510(k) clearance for the Iconix 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 Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on November 14, 2023 after a review of 21 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 Riverpoint Medical devices

Submission Details

510(k) Number K233468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2023
Decision Date November 14, 2023
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 321
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K233468.
OTS 25 (100-1)
K233429 · Ots Medical , Ltd. · Dec 2023
IDEAL Ziploop
K233552 · Riverpoint Medical · Nov 2023
Arthrex Knee FiberTak® Button Suture Anchor
K232973 · Arthrex, Inc. · Nov 2023
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
K232886 · Healthium Medtech Limited · Nov 2023
Arthrex FiberTak Suture Anchor
K232742 · Arthrex, Inc. · Nov 2023
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
K232725 · Suzhou Endophix Co., Ltd. · Nov 2023