# K050934: Modus Titanium Osteosynthesis System

- Pathway: 510(k) (Special)
- Applicant: Medartis, Inc.
- Decided: May 5, 2005 after 21 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: 2 generations back to K950045 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946165: CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System, Elekta Instruments, Inc. (1995) Summary page 1.
- K992683: Modus 2.5 Mandibular Trauma Set, Medartis AG (1999) Summary page 2.

## Most influential descendants
- K071612: Modus Trilock 2.0/2.3/2.5 (2007), 0 descendants of its own

## Indications for use
The MODUS ® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.

Source page: https://510kreport.com/device/K050934
Methodology: https://510kreport.com/methodology