# K241769: Response Ortho Metaphyseal Hinge Fixator System

- Pathway: 510(k) (Traditional)
- Applicant: Response Ortho Solutions, LLC
- Decided: Sep 18, 2024 after 90 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: 12 generations back to K962616 (1996). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001358: Ebi Xfix DFS Metaphyseal Correction System, Ebi, L.P. (2000) Summary page 5.
- K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation, Smith & Nephew (2020) Summary page 5.

## Indications for use
The Response Ortho Metaphyseal Fixation System is indicated for treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation.

Source page: https://510kreport.com/device/K241769
Methodology: https://510kreport.com/methodology