Cleared Traditional

K913735 - SONGER(TM) CABLE SYSTEM

K913735 is an FDA 510(k) clearance for SONGER(TM) CABLE SYSTEM, manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K913735 · Danek Medical, Inc. · Orthopedic device
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Nov 1991
Decision
90d
Days
Class 2
Risk

K913735 is an FDA 510(k) clearance for the SONGER(TM) CABLE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on November 18, 1991 after a review of 90 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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K913735

510(k) Number K913735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1991
Decision Date November 18, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 91
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K913735.
FX-CABLELOK SYSTEM, MODIFICATION
K915259 · Biodynamic Technologies, Inc. · Feb 1992
CODMAN SOF'WIRE (TM) KIT
K915581 · Codman & Shurtleff, Inc. · Jan 1992
DEPUY (NITINO) GUIDE WIRE
K914693 · Depuy, Inc. · Dec 1991
FX-CABLELOK SYSTEM
K912207 · Biodynamic Technologies, Inc. · Jul 1991
STERNOTOMY CABLE, SONGER CABLE SYSTEM
K903676 · Danek Medical, Inc. · Sep 1990
MENNEN BONE FIXATION DEVICE
K892411 · Dentsply Intl. · Jan 1990