Cleared Traditional

TriMed Threaded Intramedullary Nail System (K211783) - FDA 510(k) Clearance

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

K211783 · TriMed, Inc. · Orthopedic device
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Aug 2021
Decision
58d
Days
Class 2
Risk

K211783 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 August 6, 2021 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all TriMed, Inc. devices

Submission Details

510(k) Number K211783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2021
Decision Date August 06, 2021
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 417
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K211783.
Auxein Nailing System
K210792 · Auxein Medical Private Limited · Aug 2021
Auxilock Titanium Interference Screw
K203029 · Auxein Medical Private Limited · Aug 2021
PAO Cortical Screw
K211435 · Medacta International S.A. · Aug 2021
Cannulated Fasteners and Nuts
K211290 · OsteoCentric Technologies · Aug 2021
IntraLock System
K210159 · Fusion Orthopedics, LLC · Jul 2021
Medline UNITE® Digital Fusion Screw System
K211944 · Medline Industries, Inc. · Jul 2021