# K242861: TrueLok Elevate

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Dec 3, 2024 after 74 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: 14 generations back to K962616 (1996). 59 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170650: Orthofix TrueLok Hexapod System (TL-HEX) V2.0, Orthofix Srl (2017) Summary page 5.

## Most influential descendants
- K260900: DYNEX® External Fixation Systems (2026), 0 descendants of its own
- K260073: XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (2026), 0 descendants of its own
- K251862: External Fixation Bone Distractor (2025), 0 descendants of its own

## Indications for use
Truelok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The Truelok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

Source page: https://510kreport.com/device/K242861
Methodology: https://510kreport.com/methodology