Cleared Traditional

K061776 - ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE

K061776 is the FDA 510(k) clearance for ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE by Arthrotek, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K061776 · Arthrotek, Inc. · Orthopedic device
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Sep 2006
Decision
94d
Days
Class 2
Risk

K061776 is an FDA 510(k) clearance for the ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Arthrotek, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 25, 2006 after a review of 94 days - within the typical 510(k) review window.

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 Arthrotek, Inc. devices

Submission Details

510(k) Number K061776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2006
Decision Date September 25, 2006
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, 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 - JDR Staple, Fixation, Bone

All 100
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K061776.
ARTHREX COMPRESSION STAPLE
K080111 · Arthrex, Inc. · Feb 2008
BIOPRO MEMORY STAPLE, MODELS 18062-18073
K072298 · Biopro, Inc. · Oct 2007
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
K071257 · Depuy Mitek, A Johnson & Johnson Company · Jun 2007
BIOKNOTLESS AND LUPINE PLUS ANCHORS
K062170 · Depuy Mitek, A Johnson & Johnson Company · Aug 2006
BIOPRO MEMORY STAPLE
K061798 · Biopro, Inc. · Aug 2006
MEMORY STAPLE
K060746 · DePuy Orthopaedics, Inc. · May 2006