PMA · Approved
Recalled · Class II · 2018Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
Approved on Jul 2, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 557-day review. It has been recalled 8 times.
- Decided
- Jul 2, 2002
- Review
- 557 days
- Class
- Class III
- Product code
- NEK
- Recalls
- 8
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P000058 has 90 supplements since 2002: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 5 |
| 2005 | 5 |
| 2007 | 5 |
| 2008 | 5 |
| 2009 | 3 |
| 2010 | 4 |
| 2011 | 4 |
| 2012 | 6 |
| 2013 | 6 |
| 2014 | 1 |
| 2015 | 4 |
| 2016 | 3 |
| 2017 | 5 |
| 2018 | 2 |
| 2019 | 6 |
| 2020 | 4 |
| 2021 | 3 |
| 2022 | 4 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 5 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NEK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2018 | Class II | Z-0440-2019 | Error in labeling | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NEK devicesNEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEK
Too few NEK 510(k)s in any year since 2007 to give a median.
Recalls per year · NEK
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEK
49in 2025
MAUDE reports naming product code NEK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 0 | 68 |
| 2008 | 5 | — | 0 | 87 |
| 2009 | 3 | — | 0 | 232 |
| 2010 | 4 | — | 0 | 305 |
| 2011 | 4 | — | 0 | 314 |
| 2012 | 6 | — | 0 | 1,957 |
| 2013 | 6 | — | 0 | 3,497 |
| 2014 | 1 | — | 0 | 1,928 |
| 2015 | 4 | — | 0 | 1,734 |
| 2016 | 3 | — | 0 | 1,528 |
| 2017 | 5 | — | 0 | 799 |
| 2018 | 2 | — | 1 | 179 |
| 2019 | 6 | — | 0 | 37 |
| 2020 | 4 | — | 0 | 31 |
| 2021 | 3 | — | 0 | 23 |
| 2022 | 4 | — | 0 | 8 |
| 2023 | 4 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 36 |
| 2025 | 1 | — | 0 | 49 |
| 2026 | 5 | — | 0 | — |
https://510kreport.com/device/P000058 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000058: Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000058
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026