# K241563: Extremity Medical External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Feb 21, 2025 after 266 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). 82 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation, Smith & Nephew (2020) Summary page 5.
- K232838: Monkey RingsTM External Fixation System, Paragon 28, Inc. (2023) Summary page 5.
- K161417: DePuy Synthes MAXFRAME Multi-Axial Correction System, Synthes USA, LLC (2016) Summary page 5.

## Most influential descendants
- K251128: Extremity Medical External Fixation System (2025), 0 descendants of its own

## 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/K241563
Methodology: https://510kreport.com/methodology