# K094043: Ligamentotaxor

- Pathway: 510(k) (Traditional)
- Applicant: Arex USA
- Decided: Aug 17, 2010 after 229 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970713 (1997). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980370: Biosymmetric Proximal Interphalangeal Joint Fixator, Biomet, Inc. (1998) Summary page 1.
- K970713: Compass Universal Hinge, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.

## Most influential descendants
- K132731: Digifix External Fixation System (2014), 1 descendant of its own
- K192465: DigiFix Sterile Kit (2019), 0 descendants of its own
- K122415: X-Fix Dynamic External Distractor (2013), 0 descendants of its own

## Indications for use
The Ligamentotaxor is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.

Source page: https://510kreport.com/device/K094043
Methodology: https://510kreport.com/methodology