510(k) · Cleared
Clearedprodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centinel Spine, LLC · QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices
Cleared on Aug 19, 2022 as substantially equivalent to P070001 (Centinel Spine, LLC, 2007) after a 56-day review. Its family tree reaches back 1 generation to 2007. 4 later devices descend from it.
- Decided
- Aug 19, 2022
- Review
- 56 days
- Class
- Class II
- Product code
- QLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P070001 (2007). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backP070001 Prodisc TM-C Total Disc ReplacementCentinel Spine, LLC · 2007 · Recalled
- This deviceK221848 prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC · 2022
- Descendant · cites it directly · 1 of its ownK242869 prodisc® L InstrumentsCentinel Spine, LLC · 2024
- Descendant · cites it directly · 0 of its ownK262639 BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SA · 2026
- Descendant · cites it directly · 0 of its ownK253392 Synergy Disc InstrumentsSynergy Spine Solutions, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250554 prodisc® L InstrumentsCentinel Spine, LLC · 2025
Most influential descendants
Showing 4 of 4 · See all- K242869prodisc® L InstrumentsCentinel Spine, LLC · 2024 · cites it directly1descendant
- K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SA · 2026 · cites it directly0descendants
- K253392Synergy Disc InstrumentsSynergy Spine Solutions, Inc. · 2026 · cites it directly0descendants
- K250554prodisc® L InstrumentsCentinel Spine, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P070001 | Prodisc TM-C Total Disc Replacement | Centinel Spine, LLC | 2007 | 4 |
| 0 (this device) | K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments | Centinel Spine, LLC | 2022 | — |
| +1 | K242869 | prodisc® L Instruments | Centinel Spine, LLC | 2024 | — |
| +1 | K262639 | BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | 2026 | — |
| +1 | K253392 | Synergy Disc Instruments | Synergy Spine Solutions, Inc. | 2026 | — |
| +2 | K250554 | prodisc® L Instruments | Centinel Spine, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 K262639 BAGUERA® C Cervical Disc Surgical Instrumentsscore 12.1 · 2 generations · 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 |
|---|---|---|---|
| * | P070001 | Prodisc TM-C Total Disc ReplacementSummary page 5…Page 1 of 2 Primary Predicate Device: Substantial equivalence of these instruments is claimed to the Legacy prodisc C® instruments approved in P070001 prior to the down classification (Legacy prodisc C® instruments were classified in response to an Accessory Reclassification Requ… | 2007 |
What descends from it? (4)
3 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?
- Its one ancestor has a recall.
- Of its descendants, K242869 (Centinel Spine, LLC, 2024) has gone furthest, with 1 descendant 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 prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices.
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/K221848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221848: prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221848
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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