# K170650: Orthofix TrueLok Hexapod System (TL-HEX) V2.0

- Pathway: 510(k) (Special)
- Applicant: Orthofix Srl
- Decided: May 10, 2017 after 68 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962616 (1996). 58 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152171: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4, Orthofix Srl (2015) Summary page 4.

## Most influential descendants
- K242861: TrueLok Elevate (2024), 3 descendants of its own
- K193368: Smart Correction System (2020), 3 descendants of its own
- K231461: Smart Correction System (HA Half Pins) (2023), 1 descendant of its own
- K221366: Smart Correction System Rings and Compatible HA-Coated Half Pins (2022), 1 descendant of its own
- K202833: Sequel External Fixation Device (2021), 1 descendant of its own

## Recalls of this device
- Jan 30, 2018 · Class II · Z-2063-2018: The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after Septemb

## Indications for use
The TL-HEX System is intended for limb lengthening by metaphyseal or epiphyseal distractions, fixation of open and closed fractures, treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. Indications, both for adults and all pediatric subgroups except newborns, include: * Post-traumatic joint contracture which has resulted in loss of range of motion * Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction * Open and closed fracture fixation * Pseudoarthrosis of long bones * Limb lengthening by epiphyseal or metaphyseal distraction * Correction of bony or soft tissue deformities * Correction of bony or soft tissue defects » Joint arthrodesis * Infected fractures or non unions

Source page: https://510kreport.com/device/K170650
Methodology: https://510kreport.com/methodology