# K031989: Ortrautek Orthognathic System

- Pathway: 510(k) (Traditional)
- Applicant: Tekka
- Decided: Oct 28, 2003 after 123 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: 3 generations back to K953806 (1996). 12 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 18 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.
- K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS), Synthes (Usa) (1998) Summary page 1.
- K021618: Osa Rigid Internal Fixation System, Osteomed Corp. (2002) Summary page 1.
- K944561: Micro Osteosynthesis System (1.0), KLS-Martin L.P. (1994) Summary page 1.
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), 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.
- K012910: The Bioplate Mandible Fixation System, Bioplate, Inc. (2001). Our reading of the summary gave K012901, FDA’s number for Color-Monogen (Instrumentation Laboratory CO). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “The Bioplate Mandible Fixation System”. Summary page 1.

## Most influential descendants
- K091812: Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems (2010), 4 descendants of its own
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own
- K170697: GBR system (2018), 2 descendants of its own
- K222367: Save GBR (2023), 0 descendants of its own
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own

## Indications for use
The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.

Source page: https://510kreport.com/device/K031989
Methodology: https://510kreport.com/methodology