# K143336: Biomet Microfixation OmniMax MMF System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation
- Decided: Apr 1, 2015 after 132 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: 5 generations back to K820944 (1982). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061271: Erch Arch Bar, Model 38-690-00, KLS-Martin L.P. (2006) Summary page 5.
- K122313: Stryker Universal Smartlock Hybrid MMF System, Stryker (2012) Summary page 5.
- K040983: Lorenz Self-Drilling Imf Screw, Walter Lorenz Surgical, Inc. (2004) Summary page 5.

## Most influential descendants
- K173320: KLS Martin L1 MMF System (2018), 2 descendants of its own
- K241314: KLS Martin Oral-Max Implants MR Conditional (bundled) (2024), 1 descendant of its own
- K152326: Biomet Microfixation OmniMax MMF System (2015), 1 descendant of its own
- K260137: KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions (2026), 0 descendants of its own
- K202969: Biomet Microfixation OmniMax MMF System (2021), 0 descendants of its own

## 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/K143336
Methodology: https://510kreport.com/methodology