Cleared Traditional

K063017 - AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM

K063017 is the FDA 510(k) clearance for AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM by Aesculap, Inc.. It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K063017 · Aesculap, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
86d
Days
Class 2
Risk

K063017 is an FDA 510(k) clearance for the AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 27, 2006 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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: 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 Aesculap, Inc. devices

Submission Details

510(k) Number K063017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date December 27, 2006
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.

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 88
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K063017.
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
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BIOMET CABLE SYSTEM
K071271 · Biomet Manufacturing, Inc. · Oct 2007
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K050041 · Synthes (Usa) · Feb 2005
CABLING SYSTEM TROCHANTER HOOK
K043252 · Smith & Nephew, Inc. · Jan 2005
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
K033816 · Synthes (Usa) · Mar 2004