Cleared Traditional

K110426 - DYNA-EXTOR II

K110426 is the FDA 510(k) clearance for DYNA-EXTOR II by Bk Meditech, Co., Ltd.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K110426 · Bk Meditech, Co., Ltd. · Orthopedic device
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Nov 2011
Decision
261d
Days
Class 2
Risk

K110426 is an FDA 510(k) clearance for the DYNA-EXTOR II. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Bk Meditech, Co., Ltd. (Stillwater, US). The FDA issued a Cleared decision on November 2, 2011 after a review of 261 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Bk Meditech, Co., Ltd. devices

Submission Details

510(k) Number K110426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2011
Decision Date November 02, 2011
Days to Decision 261 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 122d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 248
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