Cleared Traditional

Advanced Research Medical Trident SI Screw System (K203373) - FDA 510(k) Clearance

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

K203373 · Advanced Research Medical, LLC · Orthopedic device
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Jan 2021
Decision
67d
Days
Class 2
Risk

K203373 is an FDA 510(k) clearance for the Advanced Research Medical Trident SI Screw System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Advanced Research Medical, LLC (Burnsville, US). The FDA issued a Cleared decision on January 22, 2021 after a review of 67 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 Advanced Research Medical, LLC devices

Submission Details

510(k) Number K203373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2020
Decision Date January 22, 2021
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
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

Jalex Medical
Kyle Kovach

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 - OUR Sacroiliac Joint Fixation

All 99
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K203373.
Harvester SI: Sacroiliac Fixation System
K203780 · Spinus International, Inc. · Mar 2021
iFuse-TORQ™ Implant System
K203247 · SI-BONE, Inc. · Feb 2021
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
K210035 · Aegis Spine · Feb 2021
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K203671 · Medacta International S.A. · Jan 2021
FIREBIRD SI Fusion System
K203138 · Orthofix, Inc. · Nov 2020
Life Spine SIMPACT Sacroiliac Joint Fixation System
K201538 · Life Spine, Inc. · Sep 2020