# K101338: Newfix External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Technologia Y Diseno Industrial, S.A DE C.V
- Decided: Mar 14, 2011 after 306 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: 8 generations back to K962823 (1996). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831576: Orthofix, Electro-Biology, Inc. (1983) Summary page 2.
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996). Our reading of the summary gave K955845, FDA’s number for LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod Lens (Surgical Image Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Orthofix Modulsystem Dynamic Axial Fixation System”.
- K961350: Synthes Mini External Fixator, Synthes (Usa) (1996) Summary page 2.
- K011034: Synthes (Usa) Medium External Fixation System, Synthes (Usa) (2001) Summary page 2.
- K090658: Synthes External Fixation Devices, MR Conditional, Synthes (Usa) (2010) Summary page 2.
- K091258: Extrafix External Fixation System, Qfx Technologies, Inc. (2009) Summary page 2.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 2.
- K971755: Hoffmann II Compact External Fixation System, Howmedica Corp. (1997) Summary page 2.
- K012294: Wristore Fixator, Millennium Medical Technologies, Inc. (2002) Summary page 2.
- K101254: Newfix Screw, Wire and Pin Fixarion System, Tecnologia Y Diseno Industrial, S.A DE C.V (2010). Cleared while this submission was under review Summary page 2.
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins, Treu-Instrumente GmbH (2009) Summary page 2.

## Indications for use
The Newfix® 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.

Source page: https://510kreport.com/device/K101338
Methodology: https://510kreport.com/methodology