Cleared Special

StealthFix Intraosseous Fixation System (K232324) - FDA 510(k) Clearance

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

K232324 · Medartis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
27d
Days
Class 2
Risk

K232324 is an FDA 510(k) clearance for the StealthFix Intraosseous Fixation System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Medartis, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 30, 2023 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Medartis, Inc. devices

Submission Details

510(k) Number K232324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2023
Decision Date August 30, 2023
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 65
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K232324.
A’TOMIC™ Nitinol Fixation System
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Medline UNITE® REFLEX® Nitinol Staple Kit
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Treace Medical Concepts (TMC) Compression Implant System
K232387 · Treace Medical Concepts · Aug 2023
NITINEX Memory Compression Staple
K231493 · Vilex, LLC · Aug 2023
Medline UNITE® REFLEX® Nitinol Staple System
K231885 · Medline Industries, LP · Aug 2023