# K252625: The Response Ortho Smart Fixator - Hexapod System

- Pathway: 510(k) (Traditional)
- Applicant: Response Ortho Solutions, LLC
- Decided: Nov 20, 2025 after 93 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K962616 (1996). 112 ancestors in all.
No later device cites it as a predicate yet.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193368: Smart Correction System, Wishbone Medical, Inc. (2020) Summary page 7.
- K221366: Smart Correction System Rings and Compatible HA-Coated Half Pins, Wishbone Medical, Inc. (2022) Summary page 5.
- K231461: Smart Correction System (HA Half Pins), Wishbone Medical, Inc. (2023) Summary page 7.
- K223786: Orthex External Fixation System, OrthoPediatrics Corp. (2023)
- K243798: Orthex External Fixation System, OrthoPediatrics Corp. (2025) Summary page 5.

## Indications for use
INTENDED USE The Response Ortho Smart Fixator - Hexapod System is intended for use in adult patients and pediatric patients greater than 2 through 21 years of age for the treatment of open and closed fractures, arthrodesis and pseudoarthrosis of long bones, limb lengthening, deformity and angular correction, bony or soft tissue defect correction, and malunions. This is accomplished by construction of an external fixator frame and a computer-assisted planning and correction application. Based on surgeon input of examination and radiographic measurements, the software provides a schedule of adjustments for the fixator frame. INDICATIONS FOR USE The Smart Fixator - Hexapod System is indicated for adult patients and pediatric patients greater than 2 through 21 years of age for the following: * Joint contracture resulting in loss of range of motion. * Fractures and disease which generally may result in joint contractures or loss of range of motion. * Fractures requiring distraction. * Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar). * Correction of bony or soft tissue defects. * Correction of bony or soft tissue deformities. * Joint arthrodesis. * Infected fractures or nonunion. * Limb lengthening by epiphyseal or metaphyseal distraction. * Pseudoarthrosis of long bones.

Source page: https://510kreport.com/device/K252625
Methodology: https://510kreport.com/methodology