# K032520: Ortrautek Trauma System

- Pathway: 510(k) (Traditional)
- Applicant: Tekka
- Decided: Nov 12, 2003 after 89 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954385 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 1.
- K022185: Universal CMF System, Stryker Instruments (2002) Summary page 1.
- K002619: Newgen System, Stryker Instruments (2000) Summary page 1.
- K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS), Synthes (Usa) (1998) Summary page 1.
- K944561: Micro Osteosynthesis System (1.0), KLS-Martin L.P. (1994) Summary page 1.
- K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System, Walter Lorenz Surgical, Inc. (1995) Summary page 1.

## Indications for use
The ORTRAUTEK TRAUMA SYSTEM is a cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization and rigid fixation of cranio-maxillofacial fracture and reconstruction.

Source page: https://510kreport.com/device/K032520
Methodology: https://510kreport.com/methodology