Cleared Traditional

DEPUY (NITINO) GUIDE WIRE (K914693) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914693 · Depuy, Inc. · Orthopedic device
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Dec 1991
Decision
52d
Days
Class 2
Risk

K914693 is an FDA 510(k) clearance for the DEPUY (NITINO) GUIDE WIRE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 52 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 Depuy, Inc. devices

Submission Details

510(k) Number K914693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date December 09, 1991
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 52
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K914693.
CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
K923869 · Codman & Shurtleff, Inc. · May 1993
CODMAN SOFWIRE(TM) KIT
K926116 · Codman & Shurtleff, Inc. · Mar 1993
CODMAN SOF'WIRE (TM) KIT
K915581 · Codman & Shurtleff, Inc. · Jan 1992
MENNEN BONE FIXATION DEVICE
K892411 · Dentsply Intl. · Jan 1990
BONE FIXATION WIRE
K882967 · Baxter Healthcare Corp · Sep 1988