SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)— 510(k) K250472

Name: FDA 510(k) clearance K250472
Creator: U.S. Food and Drug Administration
Published: 2025-08-08

Substantially Equivalent

Amdt Holdings, Inc.

FDA 510(k) clearance K250472 for SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS), Substantially Equivalent on 2025-08-08. Applicant: Amdt Holdings, Inc.. Device class: 2.

Clearance details

Applicant: Amdt Holdings, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-02-18
Decision date: 2025-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Collierville, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTT

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K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System2026-06-11
K260900 — DYNEX® External Fixation Systems2026-04-17
K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
K253291 — Excelsior System2026-01-20
K253202 — Hoffmann LRF System2025-12-19

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.