# K941048: True/Lok Monolateral/Bilateral Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Applied Osteo Systems, Inc.
- Decided: Oct 3, 1994 after 210 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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
No predicates in its family tree.
46 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) (2014), 32 descendants of its own
- 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
- K052005: R&R External Fixation System (2005), 11 descendants of its own

## Recalls of this device
- Sep 28, 2007 · Not classified · Z-0674-2008: Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.

Source page: https://510kreport.com/device/K941048
Methodology: https://510kreport.com/methodology