# K073135: Synthes (Usa) Hybrid External Fixator Modifications

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 29, 2008 after 83 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950384 (1995). 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)
- K950384: Synthes (Usa) Synthes Hybrid External Fixator, Synthes (Usa) (1995) Summary page 1.

## Indications for use
Fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft.

Source page: https://510kreport.com/device/K073135
Methodology: https://510kreport.com/methodology