Cleared Traditional

K031508 - SYNTHES (USA) STERNAL RECONSTRUCTION SY...

K031508 is the FDA 510(k) clearance for SYNTHES (USA) STERNAL RECONSTRUCTION SY... by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K031508 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2003
Decision
16d
Days
Class 2
Risk

K031508 is an FDA 510(k) clearance for the SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 30, 2003 after a review of 16 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 Synthes (Usa) devices

Submission Details

510(k) Number K031508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2003
Decision Date May 30, 2003
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
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 82
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K031508.
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
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · Smith & Nephew, Inc. · May 2003
SYNTHES STERNAL FIXATION SYSTEM
K010943 · Synthes (Usa) · Jun 2001
SPL CRIMP SYSTEM
K002110 · Pioneer Surgical Technology · Oct 2000