Cleared Traditional

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 179
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K250472.
The Response Ortho Smart Fixator - Hexapod System
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External Fixation Bone Distractor
K251862 · Paragon 28, Inc. · Aug 2025
Extremity Medical External Fixation System
K251128 · Extremity Medical, LLC · May 2025
Orthex External Fixation System
K243798 · OrthoPediatrics Corp. · Mar 2025
Extremity Medical External Fixation System
K241563 · Extremity Medical, LLC · Feb 2025