# K101375: Trimed X-Fix

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Sep 15, 2010 after 121 days
- Product code: NDK (System, External Fixator (With Metallic Invasive Components))
- 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: 3 generations back to K831576 (1983). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974911: External Fixator, Avanta Orthopaedics, Inc. (1998)
- K981716: External Fixation, Avanta Orthopaedics, Inc. (1998) Summary page 1.

## Most influential descendants
- K122208: External Fixator System (2012), 0 descendants of its own

## Indications for use
The TriMed X-Fix is a unilateral external fixation device. It is intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K101375
Methodology: https://510kreport.com/methodology