Cleared Traditional

K090686 - SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS

K090686 is an FDA 510(k) clearance for SIC BREVETTI S.R.L. DEVICE FOR STERNAL ..., manufactured by Sic Brevetti S.R.L.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K090686 · Sic Brevetti S.R.L. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
267d
Days
Class 2
Risk

K090686 is an FDA 510(k) clearance for the SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Sic Brevetti S.R.L. (North Attleboro, US). The FDA issued a Cleared decision on December 8, 2009 after a review of 267 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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. Standard predicate reliance. 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 Sic Brevetti S.R.L. devices

FDA 510(k) Submission Details - K090686

510(k) Number K090686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2009
Decision Date December 08, 2009
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 97
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