Cleared Special

CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET (K033519) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033519 · Biomet, Inc. · Orthopedic device
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Dec 2003
Decision
28d
Days
Class 2
Risk

K033519 is an FDA 510(k) clearance for the CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 5, 2003 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet, Inc. devices

Submission Details

510(k) Number K033519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2003
Decision Date December 05, 2003
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Peers - HRS Plate, Fixation, Bone

All 695
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K033519.
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593 · Zimmer, Inc. · Apr 2004
EVOLVE RADIAL PLATE
K033456 · Wrightmedicaltechnologyinc · Jan 2004
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · Smith & Nephew, Inc. · Dec 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666 · Arthrex, Inc. · Nov 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559 · Synthes (Usa) · Oct 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187 · Arthrex, Inc. · Sep 2003