# K122210: Newfix External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Tecnologia Y Diseno Industrial, S.A DE C.V
- Decided: Apr 19, 2013 after 268 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: 6 generations back to K993886 (1999). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 2.
- K013540: Ebi Xfix Access Pelvic Fixator, Ebi, L.P. (2001) Summary page 2.
- K012024: Ebi Xfix DFS System, Ebi, L.P. (2001) Summary page 2.
- K031919: Ebi Xfix DFS System, Ebi, L.P. (2003) Summary page 2.
- K953406: Ebi X Fix Dynafix System (DFS), Electro-Biology, Inc. (1995) Summary page 2.
- K040935: Ebi Xfix DFS System, Ebi, L.P. (2004) Summary page 2.
- K991941: Ebi Xfix DFS Rail System, Electro-Biology, Inc. (1999) Summary page 2.
- K000083: Ebi Xfix DFS Rail System, Ebi, L.P. (2000) Summary page 2.
- K010437: Modification to Ebi Xfix DFS Rail System, Ebi, L.P. (2001) Summary page 2.
- K021031: Ebi Xfix Rail System, Ebi, L.P. (2002) Summary page 2.
- K033635: Modification to Ebi Xfix Vision Fixation System, Ebi, L.P. (2003) Summary page 2.
- K081244: Lower Extremity External Fixation - Expanded Indications, Biomet Trauma (2008) Summary page 2.

## Indications for use
The Newfix®D External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures. The Newfix® External Fixation System lengthening components (rail systems) are unilateral external fixation devices and components intended for use in adults and pediatrics in the treatment of bone conditions including leg lengthening (osteotomies), arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K122210
Methodology: https://510kreport.com/methodology