# K946165: CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instruments, Inc.
- Decided: May 23, 1995 after 155 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K992682: Modus 2.5 Mandibular Reconstruction Set (1999), 2 descendants of its own
- K992683: Modus 2.5 Mandibular Trauma Set (1999), 2 descendants of its own
- 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
- K013672: Bruges Distraction - Anchoring - Osteosynthesis System (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K946165
Methodology: https://510kreport.com/methodology