Cleared Traditional

K033816 - SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM

K033816 is an FDA 510(k) clearance for SYNTHES (USA) MODIFICATION TO STERNAL R..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K033816 · Synthes (Usa) · Orthopedic device
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Mar 2004
Decision
84d
Days
Class 2
Risk

K033816 is an FDA 510(k) clearance for the SYNTHES (USA) MODIFICATION TO 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 March 2, 2004 after a review of 84 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

FDA 510(k) Submission Details - K033816

510(k) Number K033816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2003
Decision Date March 02, 2004
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 108
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K033816.
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017 · Aesculap, Inc. · Dec 2006
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K050041 · Synthes (Usa) · Feb 2005
CABLING SYSTEM TROCHANTER HOOK
K043252 · Smith & Nephew, Inc. · Jan 2005
ISO-ELASTIC CERCLAGE SYSTEM
K030256 · Kinamed, Inc. · Oct 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · Synthes (Usa) · May 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · Smith & Nephew, Inc. · May 2003