Cleared Traditional

K071374 - OPUS TWINLOCK KNOTLESS FIXATION DEVICE

K071374 is an FDA 510(k) clearance for OPUS TWINLOCK KNOTLESS FIXATION DEVICE, manufactured by Arthrocare Corp.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K071374 · Arthrocare Corp. · Orthopedic device
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Aug 2007
Decision
78d
Days
Class 2
Risk

K071374 is an FDA 510(k) clearance for the OPUS TWINLOCK KNOTLESS FIXATION DEVICE. 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 August 2, 2007 after a review of 78 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

FDA 510(k) Submission Details - K071374

510(k) Number K071374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2007
Decision Date August 02, 2007
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

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

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