Cleared Traditional

K050041 - SYNTHES (USA) STERILE STERNAL FIXATION ...

K050041 is the FDA 510(k) clearance for SYNTHES (USA) STERILE STERNAL FIXATION ... by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K050041 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
49d
Days
Class 2
Risk

K050041 is an FDA 510(k) clearance for the SYNTHES (USA) STERILE STERNAL FIXATION 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 February 25, 2005 after a review of 49 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 K050041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2005
Decision Date February 25, 2005
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 K050041.
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K091190 · Zimmer Spine, Inc. · Jul 2009
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K081205 · Synthes (Usa) · Jul 2008
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017 · Aesculap, Inc. · Dec 2006
CABLING SYSTEM TROCHANTER HOOK
K043252 · Smith & Nephew, Inc. · Jan 2005
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
K033816 · Synthes (Usa) · Mar 2004
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · Synthes (Usa) · May 2003