Cleared Traditional

ARTHREX TRIMIT SCREW, MODEL AR-4161B (K031945) - FDA 510(k) Clearance

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

K031945 · Arthrex, Inc. · Orthopedic device
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Sep 2003
Decision
90d
Days
Class 2
Risk

K031945 is an FDA 510(k) clearance for the ARTHREX TRIMIT SCREW, MODEL AR-4161B. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on September 22, 2003 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Arthrex, Inc. devices

Submission Details

510(k) Number K031945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2003
Decision Date September 22, 2003
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 Peers - HWC Screw, Fixation, Bone

All 400
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K031945.
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · Synthes (Usa) · Mar 2004
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · Biomet, Inc. · Nov 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B
K032098 · Arthrex, Inc. · Oct 2003
BIORCI SCREW
K032224 · Smith & Nephew, Inc. · Aug 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · Smith & Nephew, Inc. · Jul 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368 · KARL STORZ Endoscopy-America, Inc. · Mar 2003