510(k) · Cleared
ClearedELID (Endoscopic Less Invasive Decompression) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lesspine Innovations · HRX Arthroscope
Cleared on Aug 27, 2025 as substantially equivalent to K233800 (Vertos Medical, Inc., 2024) and 2 other predicates after a 264-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- Aug 27, 2025
- Review
- 264 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K922881 (1992). 42 ancestors in all, the oldest K844131 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
- 6 generations backK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
- 5 generations backK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
- 4 generations backK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
- 3 generations backK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- 2 generations backK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
- 1 generation backK233800 Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc. · 2024
- This deviceK243774 ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations · 2025
- Descendant · cites it directly · 0 of its ownK252546 VantageTM Lumbar Decompression KitAllevion Medical, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922881 | Clarus Models 1100, 1101, 1102, 1103 Laser Disc | Clarus Medical Systems, Inc. | 1992 | 1 |
| −6 | K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser… | Clarus Medical, LLC | 2002 | — |
| −5 | K040424 | Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy… | Clarus Medical, LLC | 2004 | 1 |
| −4 | K040919 | Nucleotome Probe Set, Model 21200 | Clarus Medical, LLC | 2004 | 1 |
| −3 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| −2 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
| −1 | K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | 2024 | — |
| 0 (this device) | K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025 | — |
| +1 | K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K233800 | Vertos mild Device Kit (MDK-0002)Summary page 5…manufacture • Device Components Predicate Devices 510k Number Trade or Proprietary Manufacturer Product Code Predicate Type K233800 Vertos mild Device Kit Vertos Medical HRX, HAE Primary K993012/K002931 METRx™ System… | 2024 |
| * | K993012 | Minimed Com-Station, Hardware-7301; Software-7311Summary page 5…Manufacturer Product Code Predicate Type K233800 Vertos mild Device Kit Vertos Medical HRX, HAE Primary K993012/K002931 METRx™ System Medtronic Sofamor Danek, Inc. HRX Additional K210741 KLS Martin… | 1999 |
| * | K002931 | Metrx SystemSummary page 5…cturer Product Code Predicate Type K233800 Vertos mild Device Kit Vertos Medical HRX, HAE Primary K993012/K002931 METRx™ System Medtronic Sofamor Danek, Inc. HRX Additional K210741 KLS Martin Neuro R… | 2000 |
| † | K210741 | KLS Martin Neuro Rongeurs | 2022 |
| † | K152734 | Kerrison Rongeurs | 2016 |
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 |
|---|---|---|---|
| K252546 | VantageTM Lumbar Decompression Kit | 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?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 42 ancestors have a recall of any class.
- Of its descendants, K252546 (Allevion Medical, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K233800.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The ELID (Endoscopic Less Invasive Decompression) system intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243774: ELID (Endoscopic Less Invasive Decompression) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243774
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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