510(k) · Cleared
ClearedDisc-FX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellman International, Inc. · HRX Arthroscope
Cleared on Feb 24, 2006 after a 191-day review. The FDA summary names no predicate by number. 38 later devices descend from it.
- Decided
- Feb 24, 2006
- Review
- 191 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 4 citing it directly.
- This deviceK052241 Disc-FX SystemEllman International, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- Descendant · 2 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
- Descendant · 3 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
- Descendant · 2 generations on · 7 of its ownK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008 · cites it directly16descendants
- K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · cites it directly14descendants
- K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 2 generations on13descendants
- K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 3 generations on7descendants
- K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc. · 2011 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052241 | Disc-FX System | Ellman International, Inc. | 2006 | — |
| +1 | K081051 | Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope | Spine View, Inc. | 2008 | — |
| +1 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| +2 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
| +3 | K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | 2018 | — |
| +2 | K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology… | Vision-Sciences, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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?
The FDA summary names no predicate by number.
What descends from it? (38)
See all 384 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?
- Of its descendants, K081051 (Spine View, Inc., 2008) has gone furthest, with 16 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Disc-FX TM System is intended for use in ablation and coagulation of intervertebral disc material during discectomy procedures in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052241: Disc-FX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052241
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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