# K073375: Newdeal Tibiaxys System

- Pathway: 510(k) (Traditional)
- Applicant: Newdeal Sas
- Decided: Feb 21, 2008 after 80 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000684 (2000). 19 ancestors in all.
73 later devices descend from it; 6 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022255: Modofocation to Synthes Ankle Arthrodesis Plates, Synthes (Usa) (2002) Summary page 2.
- K060473: TTC Plate, New Deal, S.A. (2006) Summary page 2.
- K033639: Acumed Lower Extremity Congruent Plate System, Acumed, LLC (2004) Summary page 2.

## Most influential descendants
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates (2011), 69 descendants of its own
- K100176: Ascension Ankle Fusion Plate System (2010), 56 descendants of its own
- K121425: Ortholoc 3DI Ankle Fusion Plating System (2012), 53 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K163650: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension (2017), 12 descendants of its own

## Recalls of this device
- Jan 4, 2022 · Class II · Z-0548-2022: The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
- Mar 28, 2014 · Class II · Z-1697-2014: New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 

## Indications for use
The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction, including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal TIBIAXYS Plates are fixed with the SURFIX and SURFIX ALPHA Locking System 3.5mm diameter screws and Lock screws. Anterior Plates for ankle Arthrodesis have to be fixed with the TIBIAXYS cortical 4mm diameter screws.

Source page: https://510kreport.com/device/K073375
Methodology: https://510kreport.com/methodology