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FDA 510(k)

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

K-Number: K250472 · 2025-08-08

ApplicantAmdt Holdings, Inc.
Decision Date2025-08-08
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a medical device manufactured by Amdt Holdings, Inc.. It received FDA 510(k) clearance on 2025-08-08 under approval number K250472. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a medical device that received FDA 510(k) clearance on 2025-08-08. It is manufactured by Amdt Holdings, Inc.. The 510(k) number is K250472.

When was SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) approved by the FDA?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) received FDA 510(k) clearance on 2025-08-08, under approval number K250472.

What company makes SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is manufactured by Amdt Holdings, Inc..

What is the FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

The FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is KTT.

Related Clinical Trials

NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT02091518 Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods ENROLLING_BY_INVITATION NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT07586683 OCTA Evaluation of Retinal Vascularization in Preterm Infants With or Without Bronchopulmonary Dysplasia NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41714355 The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer. Abdominal radiology (New York) (2026) PMID: 41635818 Correction: Interventional effects of mesenchymal stem cells on epithelial-mesenchymal transition in head and neck squamous cell carcinoma and underlying mechanisms: a systematic review and meta-analysis of Frontiers in immunology (2026) PMID: 41533310 Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products. Japanese journal of radiology (2026)

Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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