510(k) · Cleared
ClearedM6-C™ Single Use, Disposable Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Kinetics / Orthofix / Seaspine · QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices
Cleared on Jun 21, 2024 as substantially equivalent to K220861 (Spinal Kinetics, LLC, 2022) after a 59-day review. Its family tree reaches back 3 generations to 2020.
- Decided
- Jun 21, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- QLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P200022 (2020). No later device cites it as a predicate yet.
- Root · 3 generations backP200022 Simplify® Cervical Artificial DiscNuvasive, Inc. · 2020 · Recalled
- 2 generations backK211757 Simplify DiscNuvasive, Inc. · 2021
- 1 generation backK220861 M6-C Artificial Cervical Disc Instruments ASSpinal Kinetics, LLC · 2022
- This deviceK241117 M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P200022 | Simplify® Cervical Artificial Disc | Nuvasive, Inc. | 2020 | 1 |
| −2 | K211757 | Simplify Disc | Nuvasive, Inc. | 2021 | — |
| −1 | K220861 | M6-C Artificial Cervical Disc Instruments AS | Spinal Kinetics, LLC | 2022 | — |
| 0 (this device) | K241117 | M6-C™ Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine | 2024 | — |
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 |
|---|---|---|---|
| * | K220861 | M6-C Artificial Cervical Disc Instruments ASSummary page 4…me: Orthopedic manual surgical instrumentation for use with total disc replacement devices Primary Predicate: K220861 - M6-C Artificial Cervical Disc Instruments AS Reason for the 510(k) Submission: To introduce a single-use version of the exist… | 2022 |
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.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K220861.
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. 2024, 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 M6-C™ Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-C Artificial Cervical Disc.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241117: M6-C™ Single Use, Disposable Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241117
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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