Cleared Special

K260073 - XT3 System (FDA 510(k) Clearance)

Also includes:
XT3 System, Mini XT3 System, 40mm XT3 System, Mini, 40mm

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

K260073 · Biodynamik, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
32d
Days
Class 2
Risk

K260073 is an FDA 510(k) clearance for the XT3 System. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Biodynamik, Inc. (Lake Forest, US). The FDA issued a Cleared decision on February 10, 2026 after a review of 32 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 Biodynamik, Inc. devices

Submission Details

510(k) Number K260073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2026
Decision Date February 10, 2026
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 93
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K260073.
Meduloc Intramedullary Fracture Fixation (IFF) System
K250316 · Meduloc, LLC · Oct 2025
XT3 System
K241357 · Biodynamik, Inc. · Jan 2025
MAVERICK Mini External Fixation System
K223112 · Smith & Nephew, Inc. · Dec 2022
MAVERICK External Fixation System
K213874 · Smith & Nephew, Inc. · Feb 2022
Steinmann Pins and Kirschner Wires
K211508 · Stryker GmbH · Oct 2021
Extended HA Half Pins
K210784 · Smith & Nephew, Inc. · Apr 2021