Cleared Traditional

K090615 - OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE

K090615 is an FDA 510(k) clearance for OPUS SPEEDLOCK 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 86-day FDA review.

K090615 · Arthrocare Corp. · Orthopedic device
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Jun 2009
Decision
86d
Days
Class 2
Risk

K090615 is an FDA 510(k) clearance for the OPUS SPEEDLOCK 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. (Sunnyvale, US). The FDA issued a Cleared decision on June 3, 2009 after a review of 86 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 - K090615

510(k) Number K090615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date June 03, 2009
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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

All 564
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