Cleared Special

K263083 - Response Ortho Smart Fixator - Hexapod System

K263083 is an FDA 510(k) clearance for Response Ortho Smart Fixator - Hexapod ..., manufactured by Response Ortho Solutions, LLC. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 30-day FDA review.

K263083 · Response Ortho Solutions, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
30d
Days
Class 2
Risk

K263083 is an FDA 510(k) clearance for the Response Ortho Smart Fixator - Hexapod System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Response Ortho Solutions, LLC (Boynton Beach, US). The FDA issued a Cleared decision on October 2, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Response Ortho Solutions, LLC devices

FDA 510(k) Submission Details - K263083

510(k) Number K263083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2026
Decision Date October 02, 2026
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KTT Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Insight, Inc.
Kevin Walls

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 382
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K263083.
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System
K254087 · Synthes USA Products, LLC · Jun 2026
DYNEX® External Fixation Systems
K260900 · Vilex, LLC · Apr 2026
QuikFix External Fixator: Knee-Spanning Pack
K260112 · Stabiliz Orthopaedics, Inc. · Mar 2026
Excelsior System
K253291 · Blue Ocean Global · Jan 2026
Hoffmann LRF System
K253202 · Stryker GmbH · Dec 2025
Monkey Rings External Ring Fixation System
K253613 · Paragon 28, Inc. · Dec 2025