# K122313: Stryker Universal Smartlock Hybrid MMF System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Oct 31, 2012 after 91 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: 4 generations back to K820944 (1982). 10 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050535: Stryker MMF Screw, Stryker Instruments (2005) Summary page 1.
- K061271: Erch Arch Bar, Model 38-690-00, KLS-Martin L.P. (2006) Summary page 1.

## Most influential descendants
- K143336: Biomet Microfixation OmniMax MMF System (2015), 5 descendants of its own
- K141165: Matrixwave MMF System (2014), 4 descendants of its own
- 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

## Indications for use
The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing. The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.

Source page: https://510kreport.com/device/K122313
Methodology: https://510kreport.com/methodology