Cleared Special

K230749 - TriMed Threaded Intramedullary Nail System

K230749 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 31-day FDA review.

K230749 · TriMed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
31d
Days
Class 2
Risk

K230749 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 April 17, 2023 after a review of 31 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 K230749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2023
Decision Date April 17, 2023
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
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 K230749.
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