# P000058: Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device

- Pathway: PMA
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jul 2, 2002 after 557 days
- Product code: NEK (Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction)
- Device class: 3
- Recalls of this device: 8 (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.
- May 28, 2013 · Class II · Z-1591-2013: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
- May 28, 2013 · Class II · Z-1589-2013: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
- May 28, 2013 · Class II · Z-1592-2013: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
- May 28, 2013 · Class II · Z-1595-2013: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
- May 28, 2013 · Class II · Z-1590-2013: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
- May 28, 2013 · Class II · Z-1594-2013: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
- May 28, 2013 · Class II · Z-1593-2013: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Source page: https://510kreport.com/device/P000058
Methodology: https://510kreport.com/methodology