Cleared Traditional

K090686 - SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090686 · Sic Brevetti S.R.L. · Orthopedic device
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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

Submission Details

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.

Device Classification

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 128
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