510(k) · Cleared
ClearedCompanion Spine DIAM™ Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Companion Spine France · QLR Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Cleared on Dec 16, 2025 after an 83-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Dec 16, 2025
- Review
- 83 days
- Class
- Class II
- Product code
- QLR
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK253118 Companion Spine DIAM™ InstrumentationCompanion Spine France · 2025
- Descendant · cites it directly · 0 of its ownK253374 LimiFlex® Dynamic Sagittal Tether Instrument SetEmpirical Spine · 2026
Most influential descendants
Showing 1 of 1 · See all- K253374LimiFlex® Dynamic Sagittal Tether Instrument SetEmpirical Spine · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K253118 | Companion Spine DIAM™ Instrumentation | Companion Spine France | 2025 | — |
| +1 | K253374 | LimiFlex® Dynamic Sagittal Tether Instrument Set | Empirical Spine | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 QLR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K200824 | FDA’s K200824 is Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN… Our OCR of the scanned summary read K200824, FDA’s number for Cardinal Health SMARTGOWN Breathable Surgical Gown… (Cardinal Health200, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “coflex Interlaminar Technology Instrumentation”. Kept off the family tree. Summary page 5…r Devices, and Sterilization Wrap Containers, Trays, Cassettes & Other Accessories II QLR, KCT (888.4520, 880.6850) coflex Interlaminar Technologies Instrumentation (Q200824) The Companion Spine DIAM ™ Instrumentation is indicated for the insertion and positioning of the Companion Spine DIAM™ Spinal S… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253374 | LimiFlex® Dynamic Sagittal Tether Instrument Set | 2026 | 0 |
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?
- Of its descendants, K253374 (Empirical Spine, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QLR devicesQLR Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QLR
Too few QLR 510(k)s in any year since 2007 to give a median.
Recalls per year · QLR
No recall names QLR since 2007.
Adverse event reports per year · QLR
No MAUDE report names QLR since 2007.
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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Companion Spine DIAM ™ Instrumentation is indicated for the insertion and positioning of the Companion Spine DIAM ™ Spinal Stabilization System devices, or if required, removal of the implantable device.
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/K253118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253118: Companion Spine DIAM™ Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253118
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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