510(k) · Cleared
ClearedSimplify Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices
Cleared on Aug 20, 2021 as substantially equivalent to P200022 (Nuvasive, Inc., 2020) after a 74-day review. Its family tree reaches back 1 generation to 2020. 3 later devices descend from it.
- Decided
- Aug 20, 2021
- Review
- 74 days
- Class
- Class II
- Product code
- QLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P200022 (2020). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backP200022 Simplify® Cervical Artificial DiscNuvasive, Inc. · 2020 · Recalled
- This deviceK211757 Simplify DiscNuvasive, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK220861 M6-C Artificial Cervical Disc Instruments ASSpinal Kinetics, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK241117 M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine · 2024
- Descendant · 2 generations on · 0 of its ownK231769 activL® Next Generation InstrumentationAesculap Implants Systems, LLC · 2023
Most influential descendants
Showing 3 of 3 · See all- K220861M6-C Artificial Cervical Disc Instruments ASSpinal Kinetics, LLC · 2022 · cites it directly2descendants
- K241117M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine · 2024 · 2 generations on0descendants
- K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P200022 | Simplify® Cervical Artificial Disc | Nuvasive, Inc. | 2020 | 1 |
| 0 (this device) | K211757 | Simplify Disc | Nuvasive, Inc. | 2021 | — |
| +1 | K220861 | M6-C Artificial Cervical Disc Instruments AS | Spinal Kinetics, LLC | 2022 | — |
| +2 | K241117 | M6-C™ Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine | 2024 | — |
| +2 | K231769 | activL® Next Generation Instrumentation | Aesculap Implants Systems, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QLQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QLQ device
- #1 K221848 prodisc C SK, prodisc C Nova, and prodisc C…score 12.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P200022 | Simplify® Cervical Artificial DiscSummary page 5…under Classification Order Q200722. This 510(k) put forth a discussion to claim substantial equivalence to the Simplify Disc Inserters that were originally PMA Approved (P200022) prior to the downclassification. Technological Characteristics: The purpose of this Traditional 510(k) is to seek marketing cle… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220861 | M6-C Artificial Cervical Disc Instruments AS | 2022 | 2 |
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.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K220861 (Spinal Kinetics, LLC, 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QLQ devicesQLQ Manual Instruments Designed For Use With Total Disc Replacement Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QLQ
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QLQ
28in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QLQ
No recall names QLQ since 2007.
Adverse event reports per year · QLQ
2in 2022
MAUDE reports naming product code QLQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 28 | 0 | — |
What is it indicated for?
The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211757: Simplify Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211757
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026