Cleared Traditional

K250472 - SixFix Hexapod Fixator and Deformity An...

K250472 is an FDA 510(k) clearance for SixFix Hexapod Fixator and Deformity An..., manufactured by Amdt Holdings, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K250472 · Amdt Holdings, Inc. · Orthopedic device
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Aug 2025
Decision
171d
Days
Class 2
Risk

K250472 is an FDA 510(k) clearance for the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS). Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Amdt Holdings, Inc. (Collierville, US). The FDA issued a Cleared decision on August 8, 2025 after a review of 171 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 Amdt Holdings, Inc. devices

FDA 510(k) Submission Details - K250472

510(k) Number K250472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2025
Decision Date August 08, 2025
Days to Decision 171 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 122d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 303
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K250472.
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Extremity Medical External Fixation System
K241563 · Extremity Medical, LLC · Feb 2025