510(k) · Cleared
ClearedM6-C Artificial Cervical Disc Instruments AS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Kinetics, LLC · QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices
Cleared on Jun 2, 2022 as substantially equivalent to K211757 (Nuvasive, Inc., 2021) after a 70-day review. Its family tree reaches back 2 generations to 2020. 2 later devices descend from it.
- Decided
- Jun 2, 2022
- Review
- 70 days
- Class
- Class II
- Product code
- QLQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P200022 (2020). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP200022 Simplify® Cervical Artificial DiscNuvasive, Inc. · 2020 · Recalled
- 1 generation backK211757 Simplify DiscNuvasive, Inc. · 2021
- This deviceK220861 M6-C Artificial Cervical Disc Instruments ASSpinal Kinetics, LLC · 2022
- Descendant · cites it directly · 0 of its ownK241117 M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine · 2024
- Descendant · cites it directly · 0 of its ownK231769 activL® Next Generation InstrumentationAesculap Implants Systems, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P200022 | Simplify® Cervical Artificial Disc | Nuvasive, Inc. | 2020 | 1 |
| −1 | K211757 | Simplify Disc | Nuvasive, Inc. | 2021 | — |
| 0 (this device) | K220861 | M6-C Artificial Cervical Disc Instruments AS | Spinal Kinetics, LLC | 2022 | — |
| +1 | K241117 | M6-C™ Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine | 2024 | — |
| +1 | K231769 | activL® Next Generation Instrumentation | Aesculap Implants Systems, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211757 | Simplify DiscSummary page 4…ification Name: Orthopedic manual surgical instrumentation for use with total disc replacement devices Primary Predicate: K211757 Simplify Disc Inserter FP M6-C Artificial Cervical Disc Instrument (G6 version) Approved… | 2021 |
| Kept off the family tree | Q200722 | M6-C Artificial Cervical Disc Instrument (G6 version) Number could not be read Summary page 4…Inserter FP M6-C Artificial Cervical Disc Instrument (G6 version) Approved via PMA P170036 and reclassified in Q200722 Reason for the 510(k) Submission: Design Changes to Fin cutters, Inserters and Instrument tray assembly. Device Description: Th… |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K241117 (Spinal Kinetics / Orthofix / Seaspine, 2024) has gone furthest, with 0 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. 2022, 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 Attificial Cervical Disc Surgical Instruments 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/K220861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220861: M6-C Artificial Cervical Disc Instruments AS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220861
Report an extraction error
Are you the manufacturer?
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