# K240651: MRI Universal

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Jul 12, 2024 after 127 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 K954385 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221855: Universal CMF System, Stryker Leibinger GmbH & Co KG (2022) Summary page 8.

## Indications for use
The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. The Stryker Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy, stabilization, and rigid fixation of LeFort I fractures of the maxillofacial skeleton. The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. 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. The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. The Stryker Universal Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit. The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older. 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. The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.

Source page: https://510kreport.com/device/K240651
Methodology: https://510kreport.com/methodology