Cleared Traditional

K241357 - XT3 System

K241357 is an FDA 510(k) clearance for XT3 System, manufactured by Biodynamik, Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K241357 · Biodynamik, Inc. · Orthopedic device
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Jan 2025
Decision
253d
Days
Class 2
Risk

K241357 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 January 22, 2025 after a review of 253 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biodynamik, Inc. devices

FDA 510(k) Submission Details - K241357

510(k) Number K241357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2024
Decision Date January 22, 2025
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K241357.
XT3 System
K260073 · Biodynamik, Inc. · Feb 2026
Meduloc Intramedullary Fracture Fixation (IFF) System
K250316 · Meduloc, LLC · Oct 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