Cleared Traditional

K250316 - Meduloc Intramedullary Fracture Fixation (IFF) System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250316 · Meduloc, LLC · Orthopedic device
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Oct 2025
Decision
267d
Days
Class 2
Risk

K250316 is an FDA 510(k) clearance for the Meduloc Intramedullary Fracture Fixation (IFF) System. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Meduloc, LLC (Del Mar, US). The FDA issued a Cleared decision on October 29, 2025 after a review of 267 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 Meduloc, LLC devices

Submission Details

510(k) Number K250316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2025
Decision Date October 29, 2025
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K250316.
XT3 System
K260073 · Biodynamik, Inc. · Feb 2026
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