# K101254: Newfix Screw, Wire and Pin Fixarion System

- Pathway: 510(k) (Traditional)
- Applicant: Tecnologia Y Diseno Industrial, S.A DE C.V
- Decided: Jul 15, 2010 after 72 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 7 generations back to K962823 (1996). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins, Treu-Instrumente GmbH (2009) Summary page 2.

## Most influential descendants
- K101338: Newfix External Fixation System (2011), 0 descendants of its own

## Indications for use
The. Newfix Screw, Wire and Pin Fixation System is to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K101254
Methodology: https://510kreport.com/methodology