# K201510: Traufix osteosynthesis, osteotomy, and arthrodesis devices

- Pathway: 510(k) (Traditional)
- Applicant: Fixier S.A. DE C.V.
- Decided: Feb 18, 2022 after 623 days
- Product code: HRS (Plate, Fixation, Bone)
- 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 K981372 (1998). 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)
- K141680: AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws, Auxein Medical (2015) Summary page 7.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 8.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 8.
- K071184: Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System, Synthes (Usa) (2007) Summary page 8.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 8.
- K051986: Synthes 4.5 MM LCP Straight Reconstruction Plates, Synthes (Usa) (2005) Summary page 8.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 8.

## Indications for use
Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.

Source page: https://510kreport.com/device/K201510
Methodology: https://510kreport.com/methodology