# K992683: Modus 2.5 Mandibular Trauma 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 K950045 (1995). 3 ancestors in all.
2 later devices descend 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)
- K950045: KLS-Martin Mandibular Fracture/Reconstruction System, Karl Leibinger GmbH U. Co. KG (1995) Summary page 1.
- K961421: Synthes 2.4 MM Universal Locking Plate System, Synthes (Usa) (1996) Summary page 1.
- K946165: CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System, Elekta Instruments, Inc. (1995) Summary page 1.
- (no number) W. Lorenz — 2.4 Fracture System: named in the summary without a submission number
- (no number) Leibinger — CMF Modular Plating System: named in the summary without a submission number

## Most influential descendants
- K050934: Modus Titanium Osteosynthesis System (2005), 1 descendant of its own
- K071612: Modus Trilock 2.0/2.3/2.5 (2007), 0 descendants of its own

## Indications for use
The MODUS® 2.5 Trauma Set is intended for use in mandibular trauma fractures, e. g. in unstable, comminuted mandibular fractures and bone loss.

Source page: https://510kreport.com/device/K992683
Methodology: https://510kreport.com/methodology