510(k) · Cleared
Clearedprodisc® L 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 Apr 25, 2025 as substantially equivalent to K242869 (Centinel Spine, LLC, 2024) after a 59-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Apr 25, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- QLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P070001 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backP070001 Prodisc TM-C Total Disc ReplacementCentinel Spine, LLC · 2007 · Recalled
- 2 generations backK221848 prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC · 2022
- 1 generation backK242869 prodisc® L InstrumentsCentinel Spine, LLC · 2024
- This deviceK250554 prodisc® L InstrumentsCentinel Spine, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P070001 | Prodisc TM-C Total Disc Replacement | Centinel Spine, LLC | 2007 | 4 |
| −2 | 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 | — |
| 0 (this device) | K250554 | prodisc® L Instruments | Centinel Spine, LLC | 2025 | — |
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 |
|---|---|---|---|
| * | K242869 | prodisc® L InstrumentsSummary page 6…lly equivalent to the following primary predicate device with respect to intended use, design, and materials: • prodisc® L Instruments, Centinel Spine LLC, K242869 Substantial Equivalence: The subject device was demonstrated to be substantially equivalent to the predicate devices with resp… | 2024 |
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 18 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2025, 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® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250554 · printed Nov 3, 2026
Cite this page
510(k) Report. “K250554: prodisc® L Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K250554
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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