# K202969: Biomet Microfixation OmniMax MMF System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation
- Decided: Aug 5, 2021 after 309 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: 7 generations back to K820944 (1982). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152326: Biomet Microfixation OmniMax MMF System, Biomet Microfixation (2015) Summary page 5.

## Indications for use
The Biomet Microfixation OmniMax MMF System is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.

Source page: https://510kreport.com/device/K202969
Methodology: https://510kreport.com/methodology