Cleared Traditional

K121541 - JAZZ SYSTEM

K121541 is an FDA 510(k) clearance for JAZZ SYSTEM, manufactured by Implanet, S.A.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K121541 · Implanet, S.A. · Orthopedic device
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Sep 2012
Decision
112d
Days
Class 2
Risk

K121541 is an FDA 510(k) clearance for the JAZZ SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Implanet, S.A. (Philedelphia, US). The FDA issued a Cleared decision on September 13, 2012 after a review of 112 days - within the typical 510(k) review window.

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 Implanet, S.A. devices

FDA 510(k) Submission Details - K121541

510(k) Number K121541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2012
Decision Date September 13, 2012
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 94
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K121541.
Suture Wires and Wire Loops
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PERI-PROSTHETIC CABLE SYSTEM
K133354 · Biomet, Inc. · Jan 2014
TRITIUM STERNAL CABLE PLATE SYSTEM
K133785 · Pioneer Surgical Technology, Inc. · Jan 2014
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177 · Spinal Elements, Inc. · Jul 2012
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011
K2M COCR WIRE
K103797 · K2m, Inc. · May 2011