# K992682: Modus 2.5 Mandibular Reconstruction Set

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Nov 24, 1999 after 106 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: 1 generation back to K946165 (1995). 3 ancestors in all.
2 later devices descend from it; 2 cite 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.
- K954385: Synthes Mandibular Modular Fixation System, Synthes (Usa) (1996) Summary page 1.
- K961421: Synthes 2.4 MM Universal Locking Plate System, Synthes (Usa) (1996) Summary page 1.
- (no number) Stryker® Leibinger MARX™ TITANIUM Mandibular Bridging Plate System: named in the summary without a submission number
- (no number) Stryker® Leibinger TITANIUM Locking Screw Mandibular Reconstruction Plating System: named in the summary without a submission number
- (no number) Synthes® Universal Locking Plate System: named in the summary without a submission number

## Most influential descendants
- K071612: Modus Trilock 2.0/2.3/2.5 (2007), 0 descendants of its own
- K013672: Bruges Distraction - Anchoring - Osteosynthesis System (2002), 0 descendants of its own

## Indications for use
The indications for use of the MODUS® 2.5 Reconstruction Set include use in reconstruction surgery, including bone grafting and bridging defects in the mandible after tumor resection or severe infection. It is also indicated for use in mandibular trauma, e.g. unstable, comminuted mandibular fractures and bone loss.

Source page: https://510kreport.com/device/K992682
Methodology: https://510kreport.com/methodology