Cleared Special

K081497 - OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (...

K081497 is the FDA 510(k) clearance for OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (... by Arthrocare Corp.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 60-day FDA review.

K081497 · Arthrocare Corp. · Orthopedic device
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Jul 2008
Decision
60d
Days
Class 2
Risk

K081497 is an FDA 510(k) clearance for the OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS.... 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 July 28, 2008 after a review of 60 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. 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 Arthrocare Corp. devices

Submission Details

510(k) Number K081497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2008
Decision Date July 28, 2008
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

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 K081497.
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
K083240 · Arthrocare Corp. · 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
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K080335 · Tornier, Inc. · Apr 2008
OPUS TWINLOCK KNOTLESS FIXATION DEVICE
K071374 · Arthrocare Corp. · Aug 2007
STRYKER PEEK TWINLOOP TAC
K070882 · Stryker Endoscopy · Jul 2007