Cleared Special

K234040 - TriMed Threaded Intramedullary Nail System

K234040 is the FDA 510(k) clearance for TriMed Threaded Intramedullary Nail System by TriMed, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 28-day FDA review.

K234040 · TriMed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2024
Decision
28d
Days
Class 2
Risk

K234040 is an FDA 510(k) clearance for the TriMed Threaded Intramedullary Nail System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by TriMed, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on January 18, 2024 after a review of 28 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 TriMed, Inc. devices

Submission Details

510(k) Number K234040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2023
Decision Date January 18, 2024
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 Consultant

Tech2med, LLC
David Anderson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K234040.
OSSIOfiber® Threaded Trimmable Fixation Nails
K233198 · OSSIO , Ltd. · Mar 2024
SnapHammer Hammertoe Correction System
K231453 · Nvision Biomedical Technologies, Inc. · Feb 2024
TDM Screw System
K231860 · Tdm Co., Ltd. · Jan 2024
Zimed Distal Medial Tibial Plate and Screw System
K230507 · Zimed Medikal · Jan 2024
Cannulated Screw System
K233396 · Smith & Nephew, Inc. · Dec 2023
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
K232251 · Medartis AG · Nov 2023