Cleared Traditional

K925812 - TITANIUM SONGER CABLE SYSTEM

K925812 is an FDA 510(k) clearance for TITANIUM SONGER CABLE SYSTEM, manufactured by Sofamor Danek Mfg., Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K925812 · Sofamor Danek Mfg., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
132d
Days
Class 2
Risk

K925812 is an FDA 510(k) clearance for the TITANIUM SONGER CABLE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on March 24, 1993 after a review of 132 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 Sofamor Danek Mfg., Inc. devices

FDA 510(k) Submission Details - K925812

510(k) Number K925812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date March 24, 1993
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 92
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K925812.
ORTHOPAEDIC POLYETHYLENE CABLE
K924141 · Smith & Nephew Richards, Inc. · Nov 1993
CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
K923869 · Codman & Shurtleff, Inc. · May 1993
CODMAN SOFWIRE(TM) KIT
K926116 · Codman & Shurtleff, Inc. · Mar 1993
SONGER CABLE SYSTEM
K922952 · Pioneer Surgical Technology · Feb 1993
OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM
K921480 · Acu Med, Inc. · Jun 1992
FX-CABLELOK SYSTEM, MODIFICATION
K915259 · Biodynamic Technologies, Inc. · Feb 1992