Cleared Traditional

K983577 - ARTHREX MENISCAL DART SYSTEM

K983577 is the FDA 510(k) clearance for ARTHREX MENISCAL DART SYSTEM by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K983577 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
304d
Days
Class 2
Risk

K983577 is an FDA 510(k) clearance for the ARTHREX MENISCAL DART SYSTEM. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 13, 1999 after a review of 304 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 Arthrex, Inc. devices

Submission Details

510(k) Number K983577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date August 13, 1999
Days to Decision 304 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 122d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 162
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K983577.
TITAN RC TACK
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ENDOPEARL WITH THREADER
K993339 · Linvatec Corp. · Dec 1999
STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM
K993061 · Stryker Instruments · Nov 1999
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
K991715 · Linvatec Corp. · Aug 1999
RC BUTTRESS
K991009 · Biomet, Inc. · Jun 1999
ENDOPEARL
K984171 · Linvatec Corp. · Apr 1999