# K071612: Modus Trilock 2.0/2.3/2.5

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Sep 11, 2007 after 90 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)
- K992682: Modus 2.5 Mandibular Reconstruction Set, Medartis AG (1999) Summary page 2.
- K050934: Modus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 2.
- K032442: KLS-Martin Mandibular/Reconstruction System II, KLS-Martin L.P. (2003) Summary page 2.
- K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS), Synthes (Usa) (1998) Summary page 2.
- K961421: Synthes 2.4 MM Universal Locking Plate System, Synthes (Usa) (1996) Summary page 2.
- K000594: Locking Screw Mandibular Reconstruction Plate, Stryker Leibinger (2000) Summary page 2.
- K030448: Osteomed 2.0 Locking Plates and Screws, Osteomed LP (2003) Summary page 2.

## Indications for use
The MODUS® TriLock® 2.0/2.3/2.5 is intended for use in the mandible and mid-face region for osteotomies, severe fractures and comminuted fractures. These fractures may include condylar neck fractures, mandibular angle fractures, symphysis fractures, fractures of the atrophic mandible and fractures of the orbit and zygoma complex. Mandibular reconstruction may be performed with free or vascular bone graft.

Source page: https://510kreport.com/device/K071612
Methodology: https://510kreport.com/methodology