# K152171: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Sep 28, 2015 after 55 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). 57 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143125: Orthofix True Lok Hexapod System VI.3, Orthofix Srl (2014) Summary page 4.

## Most influential descendants
- K170650: Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (2017), 11 descendants of its own
- K180539: Deformity Analysis and Correction Software (DACS) and Instrumentation (2018), 4 descendants of its own
- K242861: TrueLok Elevate (2024), 3 descendants of its own
- K193368: Smart Correction System (2020), 3 descendants of its own
- K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (2019), 3 descendants of its own

## 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. 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/K152171
Methodology: https://510kreport.com/methodology