# K251128: Extremity Medical External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Extremity Medical, LLC
- Decided: May 7, 2025 after 26 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: 13 generations back to K962616 (1996). 83 ancestors in all.
No later device cites it as a predicate yet.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241563: Extremity Medical External Fixation System, Extremity Medical, LLC (2025) 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.
- K161417: DePuy Synthes MAXFRAME Multi-Axial Correction System, Synthes USA, LLC (2016) Summary page 5.

## Indications for use
The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of: Open and closed fractures Osteotomies Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis, infected union, non-union, or malunion of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity (orthoplastic surgery) Joint arthrodesis Infected fractures Correction of segmental bony or soft tissue defects Management of comminuted intra-articular fractures Bone transport Revision procedures where other treatments or devices have been unsuccessful Bone reconstruction procedures Charcot foot reconstruction Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle Ankle distraction (arthrodiastasis) Septic fusion

Source page: https://510kreport.com/device/K251128
Methodology: https://510kreport.com/methodology