# K212044: TrueLok Evo

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Nov 5, 2021 after 128 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: 1 generation back to K941048 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941048: True/Lok Monolateral/Bilateral Fixator, Applied Osteo Systems, Inc. (1994) Summary page 4.

## Indications for use
The TrueLok™ EVO is intended to provide bone fixation. The TrueLok™ EVO is indicated for fractures, pseudarthrosis / non-unions, lengthening, joint arthrodesis and correction of bony or soft tissue deformities and defects (e.g. bone transport) in long bones and in the foot.

Source page: https://510kreport.com/device/K212044
Methodology: https://510kreport.com/methodology