Cleared Traditional

K925447 - OTI ORTHOPEDIC WIRE SYSTEM

K925447 is an FDA 510(k) clearance for OTI ORTHOPEDIC WIRE SYSTEM, manufactured by Osteo Technology, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K925447 · Osteo Technology, Inc. · Orthopedic device
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Jun 1993
Decision
244d
Days
Class 2
Risk

K925447 is an FDA 510(k) clearance for the OTI ORTHOPEDIC WIRE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on June 29, 1993 after a review of 244 days - an extended review 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: 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 Technology, Inc. devices

FDA 510(k) Submission Details - K925447

510(k) Number K925447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1992
Decision Date June 29, 1993
Days to Decision 244 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
122d slower than avg
Panel avg: 122d · This submission: 244d
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 95
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K925447.
CERCLAGE WIRE CRIMP SLEEVE
K931246 · Acu Med, Inc. · Feb 1994
SPONGER CABLE SYSTEM, MODIFICATION
K935481 · Pioneer Surgical Technology · Jan 1994
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
TITANIUM SONGER CABLE SYSTEM
K925812 · Sofamor Danek Mfg., Inc. · Mar 1993