Cleared Traditional

K914374 - OSTEO CERCLAGE WIRE

K914374 is an FDA 510(k) clearance for OSTEO CERCLAGE WIRE, manufactured by Osteo AG. 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.

K914374 · Osteo AG · Orthopedic device
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Dec 1991
Decision
90d
Days
Class 2
Risk

K914374 is an FDA 510(k) clearance for the OSTEO CERCLAGE WIRE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Osteo AG (Greenwood, US). The FDA issued a Cleared decision on December 30, 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 Osteo AG devices

FDA 510(k) Submission Details - K914374

510(k) Number K914374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date December 30, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 111
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K914374.
TITANIUM ALLOY SONGER CABLE SYSTEM
K920201 · Sofamor Danek Mfg., Inc. · Apr 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
SONGER(TM) CABLE SYSTEM
K913735 · Danek Medical, Inc. · Nov 1991
FX-CABLELOK SYSTEM
K912207 · Biodynamic Technologies, Inc. · Jul 1991