Cleared Traditional

K915259 - FX-CABLELOK SYSTEM, MODIFICATION (FDA 510(k) Clearance)

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

K915259 · Biodynamic Technologies, Inc. · Orthopedic device
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Feb 1992
Decision
80d
Days
Class 2
Risk

K915259 is an FDA 510(k) clearance for the FX-CABLELOK SYSTEM, MODIFICATION. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Biodynamic Technologies, Inc. (Arlington, US). The FDA issued a Cleared decision on February 7, 1992 after a review of 80 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 Biodynamic Technologies, Inc. devices

Submission Details

510(k) Number K915259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date February 07, 1992
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 128
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