# P050053: Infuse Bone Graft

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Mar 9, 2007 after 434 days
- Product code: NPZ (Bone Grafting Material, Dental, With Biologic Component)
- Device class: 3
- Regulation: 21 CFR 872.3930
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 27, 2018 · Class II · Z-0440-2019: The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

Source page: https://510kreport.com/device/P050053
Methodology: https://510kreport.com/methodology