PMA · Approved
Recalled · Class II · 2018Prestige LP Cervical Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MJO Prosthesis, Intervertebral Disc
Approved on Jul 24, 2014 through premarket approval, which rests on the device’s own clinical evidence after a 1,675-day review. It has been recalled once.
- Decided
- Jul 24, 2014
- Review
- 1,675 days
- Class
- Class III
- Product code
- MJO
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P090029 has 20 supplements since 2015: 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 |
|---|---|
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 3 |
| 2023 | 2 |
| 2024 | 3 |
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 MJO? 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 |
|---|---|---|---|---|
| Mar 13, 2018 | Class II | Z-1641-2018 | Under Investigation by firm | The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MJO devicesMJO Prosthesis, Intervertebral Disc: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MJO
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJO
Too few MJO 510(k)s in any year since 2007 to give a median.
Recalls per year · MJO
6in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJO
262in 2025
MAUDE reports naming product code MJO, 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 | 4 | — | 6 | 278 |
| 2008 | 5 | — | 0 | 104 |
| 2009 | 1 | — | 0 | 283 |
| 2010 | 6 | — | 0 | 174 |
| 2011 | 11 | — | 0 | 251 |
| 2012 | 6 | — | 0 | 314 |
| 2013 | 12 | — | 0 | 371 |
| 2014 | 25 | — | 0 | 328 |
| 2015 | 11 | — | 0 | 724 |
| 2016 | 14 | — | 0 | 161 |
| 2017 | 15 | — | 0 | 277 |
| 2018 | 9 | — | 0 | 369 |
| 2019 | 12 | — | 0 | 380 |
| 2020 | 21 | — | 0 | 345 |
| 2021 | 17 | — | 0 | 308 |
| 2022 | 11 | — | 0 | 263 |
| 2023 | 12 | — | 0 | 278 |
| 2024 | 13 | — | 0 | 315 |
| 2025 | 13 | — | 0 | 262 |
| 2026 | 14 | — | 2 | — |
https://510kreport.com/device/P090029 · printed Nov 6, 2026
Cite this page
510(k) Report. “P090029: Prestige LP Cervical Disc.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P090029
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026