Cleared Traditional

K171690 - Trident Extremity Fixation System

K171690 is the FDA 510(k) clearance for Trident Extremity Fixation System by Trident Orthopedics. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K171690 · Trident Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
335d
Days
Class 2
Risk

K171690 is an FDA 510(k) clearance for the Trident Extremity Fixation System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Trident Orthopedics (Millersville, US). The FDA issued a Cleared decision on May 8, 2018 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Elevated predicate reliance profile. 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 Trident Orthopedics devices

Submission Details

510(k) Number K171690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2017
Decision Date May 08, 2018
Days to Decision 335 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
213d slower than avg
Panel avg: 122d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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

Wagoner Consulting, LLC
Al Memmolo

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 - HRS Plate, Fixation, Bone

All 914
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K171690.
AlignX Ankle Fusion System
K181067 · Extremity Medical, LLC · May 2018
Omni Foot Plating System
K180808 · Extremity Medical, LLC · May 2018
Additive Orthopaedics Patient Specific 3D Printed Bone Segments
K180239 · Additive Orthopaedics, LLC · May 2018
A. L. P. S. Clavicle Plating System
K173767 · Biomet, Inc. · Apr 2018
IXOS Radius Plate System
K171624 · Stuckenbrock Medizintechnik GmbH · Mar 2018
Anchorage Bone Plating System
K172148 · Stryker GmbH · Mar 2018