Cleared Traditional

K130613 - CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM

K130613 is an FDA 510(k) clearance for CANNULATED SCREW AND KIRSCHNER (KWIRE) ..., manufactured by Laura Cattabriga. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K130613 · Laura Cattabriga · Orthopedic device
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Jan 2014
Decision
321d
Days
Class 2
Risk

K130613 is an FDA 510(k) clearance for the CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Laura Cattabriga (N. Bay Village, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Laura Cattabriga devices

FDA 510(k) Submission Details - K130613

510(k) Number K130613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date January 22, 2014
Days to Decision 321 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
199d slower than avg
Panel avg: 122d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K130613.
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K132910 · Synthes USA Products, LLC · Dec 2013