Cleared Traditional

K920201 - TITANIUM ALLOY SONGER CABLE SYSTEM

K920201 is an FDA 510(k) clearance for TITANIUM ALLOY 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 84-day FDA review.

K920201 · Sofamor Danek Mfg., Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
84d
Days
Class 2
Risk

K920201 is an FDA 510(k) clearance for the TITANIUM ALLOY 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 April 8, 1992 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 Sofamor Danek Mfg., Inc. devices

FDA 510(k) Submission Details - K920201

510(k) Number K920201 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 15, 1992
Decision Date April 08, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
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 93
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K920201.
TITANIUM SONGER CABLE SYSTEM
K925812 · Sofamor Danek Mfg., 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
CODMAN SOF'WIRE (TM) KIT
K915581 · Codman & Shurtleff, Inc. · Jan 1992
DEPUY (NITINO) GUIDE WIRE
K914693 · Depuy, Inc. · Dec 1991