# K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Sep 2, 2014 after 130 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: 10 generations back to K962616 (1996). 55 ancestors in all.
32 later devices descend from it; 5 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 4.
- K941048: True/Lok Monolateral/Bilateral Fixator, Applied Osteo Systems, Inc. (1994) Summary page 4.
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 4.

## Most influential descendants
- K143125: Orthofix True Lok Hexapod System VI.3 (2014), 26 descendants of its own
- K152171: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 (2015), 19 descendants of its own
- K170650: Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (2017), 11 descendants of its own
- K151881: X-Fix Line Additions (2016), 7 descendants of its own
- K170888: Renovis S141 Lumbar Interbody Fusion System (2017), 5 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. Within this range, indications 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/K141078
Methodology: https://510kreport.com/methodology