# K061759: Reprocessed External Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Sep 5, 2006 after 75 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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 K984357 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984357: Transfx External Fixation System, Immedica, Inc. (1999) Summary page 1.
- K990848: Transfx Intermediate External Fixation System,Transfx Small External Fixation System, Transfx Mini External Fixation, Immedica, Inc. (1999) Summary page 1.
- K991723: Transfx Multi Pin Clamp, Immedica, Inc. (1999) Summary page 1.
- K001084: Trans FX Adjustable Pin to Bar Clamp, Immedica, Inc. (2000) Summary page 1.

## Indications for use
Zimmer TransFx External Fixation Devices are indicated for fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular fractures.

Source page: https://510kreport.com/device/K061759
Methodology: https://510kreport.com/methodology