PMA · Approved
Recalled · Class II · 2022Simplify® Cervical Artificial Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · MJO Prosthesis, Intervertebral Disc
Approved on Sep 18, 2020 through premarket approval, which rests on the device’s own clinical evidence after a 177-day review. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 18, 2020
- Review
- 177 days
- Class
- Class III
- Product code
- MJO
- Recalls
- 1
4 later devices descend from it, 1 citing it directly.
- This deviceP200022 Simplify® Cervical Artificial DiscNuvasive, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK211757 Simplify DiscNuvasive, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK220861 M6-C Artificial Cervical Disc Instruments ASSpinal Kinetics, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK241117 M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine · 2024
- Descendant · 3 generations on · 0 of its ownK231769 activL® Next Generation InstrumentationAesculap Implants Systems, LLC · 2023
Most influential descendants
Showing 4 of 4 · See all- K211757Simplify DiscNuvasive, Inc. · 2021 · cites it directly3descendants
- K220861M6-C Artificial Cervical Disc Instruments ASSpinal Kinetics, LLC · 2022 · 2 generations on2descendants
- K241117M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine · 2024 · 3 generations on0descendants
- K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P200022 | Simplify® Cervical Artificial Disc | Nuvasive, Inc. | 2020 | — |
| +1 | K211757 | Simplify Disc | Nuvasive, Inc. | 2021 | — |
| +2 | K220861 | M6-C Artificial Cervical Disc Instruments AS | Spinal Kinetics, LLC | 2022 | — |
| +3 | K241117 | M6-C™ Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine | 2024 | — |
| +3 | K231769 | activL® Next Generation Instrumentation | Aesculap Implants Systems, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211757 | Simplify Disc | 2021 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2022 | Class II | Z-1453-2022 | Labeling Change Control | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211757 (Nuvasive, Inc., 2021) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MJO devicesMJO Prosthesis, Intervertebral Disc: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/P200022 · printed Nov 5, 2026
Cite this page
510(k) Report. “P200022: Simplify® Cervical Artificial Disc.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P200022
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026