Response Ortho Smart Fixator - Hexapod System— 510(k) K263083

Name: FDA 510(k) clearance K263083
Creator: U.S. Food and Drug Administration
Published: 2026-10-02

Substantially Equivalent

Response Ortho Solutions, LLC

FDA 510(k) clearance K263083 for Response Ortho Smart Fixator - Hexapod System, Substantially Equivalent on 2026-10-02. Applicant: Response Ortho Solutions, LLC. Device class: 2.

Clearance details

Applicant: Response Ortho Solutions, LLC
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-09-02
Decision date: 2026-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Boynton Beach, FL, US

Download summary PDF View on FDA.gov ↗

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K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
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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.

Clearance details

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Adverse events under product code KTT