Cleared Traditional

K083240 - OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS...

K083240 is the FDA 510(k) clearance for OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS... by Arthrocare Corp.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K083240 · Arthrocare Corp. · Orthopedic device
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Jan 2009
Decision
70d
Days
Class 2
Risk

K083240 is an FDA 510(k) clearance for the OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Arthrocare Corp. (Irvine, US). The FDA issued a Cleared decision on January 12, 2009 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrocare Corp. devices

Submission Details

510(k) Number K083240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2008
Decision Date January 12, 2009
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 390
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K083240.
OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
K090615 · Arthrocare Corp. · Jun 2009
MAGNUM M FIXATION DEVICE
K090380 · Arthrocare Corp. · Mar 2009
G-FORCE TENODESIS SCREW
K083150 · Wrightmedicaltechnologyinc · Jan 2009
TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
K081348 · TriMed, Inc. · Oct 2008
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
K081511 · Smith & Nephew, Inc. · Aug 2008
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)
K081497 · Arthrocare Corp. · Jul 2008