PMA · Approved
ApprovedProdisc -L Total Disc Replacement Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centinel Spine, LLC · MJO Prosthesis, Intervertebral Disc
Approved on Aug 14, 2006 through premarket approval, which rests on the device’s own clinical evidence after a 517-day review.
- Decided
- Aug 14, 2006
- Review
- 517 days
- Class
- Class III
- Product code
- MJO
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P050010 has 25 supplements since 2008: 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 |
|---|---|
| 2008 | 3 |
| 2010 | 2 |
| 2011 | 5 |
| 2012 | 1 |
| 2014 | 3 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 4 |
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)
No FDA recall names this device.
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.
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/P050010 · printed Nov 4, 2026
Cite this page
510(k) Report. “P050010: Prodisc -L Total Disc Replacement Device.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P050010
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026