Cleared Traditional

K031666 - ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS

K031666 is an FDA 510(k) clearance for ARTHREX FIBERWIRE BUTTON REPAIR KIT, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K031666 · Arthrex, Inc. · Orthopedic device
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Nov 2003
Decision
173d
Days
Class 2
Risk

K031666 is an FDA 510(k) clearance for the ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 18, 2003 after a review of 173 days - an extended review cycle.

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. 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

FDA 510(k) Submission Details - K031666

510(k) Number K031666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2003
Decision Date November 18, 2003
Days to Decision 173 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
51d slower than avg
Panel avg: 122d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 Peers - HRS Plate, Fixation, Bone

All 1250
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K031666.
EVOLVE RADIAL PLATE
K033456 · Wrightmedicaltechnologyinc · Jan 2004
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · Smith & Nephew, Inc. · Dec 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519 · Biomet, Inc. · Dec 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559 · Synthes (Usa) · Oct 2003
KLS-MARTIN STERNAL PLATING SYSTEM
K032413 · KLS-Martin L.P. · Oct 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187 · Arthrex, Inc. · Sep 2003