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FDA 510(k)

The Response Ortho Smart Fixator - Hexapod System

K-Number: K252625 · 2025-11-20

ApplicantResponse Ortho Solutions, LLC
Decision Date2025-11-20
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Response Ortho Smart Fixator - Hexapod System is a medical device manufactured by Response Ortho Solutions, LLC. It received FDA 510(k) clearance on 2025-11-20 under approval number K252625. 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 The Response Ortho Smart Fixator - Hexapod System?

The Response Ortho Smart Fixator - Hexapod System is a medical device that received FDA 510(k) clearance on 2025-11-20. It is manufactured by Response Ortho Solutions, LLC. The 510(k) number is K252625.

When was The Response Ortho Smart Fixator - Hexapod System approved by the FDA?

The Response Ortho Smart Fixator - Hexapod System received FDA 510(k) clearance on 2025-11-20, under approval number K252625.

What company makes The Response Ortho Smart Fixator - Hexapod System?

The Response Ortho Smart Fixator - Hexapod System is manufactured by Response Ortho Solutions, LLC.

What is the FDA product code for The Response Ortho Smart Fixator - Hexapod System?

The FDA product code for The Response Ortho Smart Fixator - Hexapod System is KTT.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Response Ortho Solutions, LLC

K241769Response Ortho Metaphyseal Hinge Fixator System

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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