510(k) · Cleared
ClearedLimiFlex® Dynamic Sagittal Tether Instrument Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empirical Spine · SGL Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
Cleared on Jun 16, 2026 as substantially equivalent to K253118 (Companion Spine France, 2025) after a 259-day review. Its family tree reaches back 1 generation to 2025.
- Decided
- Jun 16, 2026
- Review
- 259 days
- Class
- Class II
- Product code
- SGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K253118 (2025). No later device cites it as a predicate yet.
- Root · 1 generation backK253118 Companion Spine DIAM™ InstrumentationCompanion Spine France · 2025
- This deviceK253374 LimiFlex® Dynamic Sagittal Tether Instrument SetEmpirical Spine · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K253118 | Companion Spine DIAM™ Instrumentation | Companion Spine France | 2025 | — |
| 0 (this device) | K253374 | LimiFlex® Dynamic Sagittal Tether Instrument Set | Empirical Spine | 2026 | — |
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 SGL? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K253118 | Companion Spine DIAM™ Instrumentation Cleared while this submission was under review Summary page 5…ys, cassettes, & other accessories Regulatory Class: II Product Codes: SGL, KCT Primary Predicate: K253118 Companion Spine DIAM™ Instrumentation. Indications For Use: The LimiFlex® Dynamic Sagittal Tether Instrument Set is intended to… | 2025 |
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?
- Its one ancestor has no recall.
How does its category compare?
All SGL devicesSGL Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SGL
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SGL
Too few SGL 510(k)s in any year since 2007 to give a median.
Recalls per year · SGL
No recall names SGL since 2007.
Adverse event reports per year · SGL
No MAUDE report names SGL 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 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The LimiFlex® Dynamic Sagittal Tether Instrument Set is intended to facilitate the implantation of the LimiFlex® Dynamic Sagittal Tether implant. The actual therapeutic effect is achieved by the LimiFlex® Dynamic Sagittal Tether implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253374: LimiFlex® Dynamic Sagittal Tether Instrument Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253374
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026