# K984357: Transfx External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Immedica, Inc.
- Decided: Mar 4, 1999 after 87 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K131413: Xtrafix Small External Fixation System (2014), 2 descendants of its own
- K110965: Renovis T 710 Large External Fixation System (2011), 2 descendants of its own
- K021933: Tempfix External Fixation System (2002), 2 descendants of its own
- K141697: Xtrafix External Fixation System, Xtrafix Small External Fixation System (2014), 1 descendant of its own
- K213905: ONX Large External Fixation System (2022), 0 descendants of its own

## Recalls of this device
- May 1, 2009 · Not classified · Z-1533-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1532-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1538-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1534-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1535-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1536-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1537-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

## Indications for use
Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fracture -

Source page: https://510kreport.com/device/K984357
Methodology: https://510kreport.com/methodology