510(k) · Cleared
ClearedEnspire Discectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine View, Inc. · HRX Arthroscope
Cleared on Jun 26, 2012 as substantially equivalent to K110992 (Spine View, Inc., 2011) after a 112-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Jun 26, 2012
- Review
- 112 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K991794 (1999). 27 ancestors in all, the oldest K844131 (1984). No later device cites it as a predicate yet.
- Root · 7 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
- 6 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
- 5 generations backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 4 generations backK061345 Modification to Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 3 generations backK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
- 2 generations backK090278 Enspire Debrider SystemSpine View, Inc. · 2009
- 1 generation backK110992 Enspire Debrider SystemSpine View, Inc. · 2011
- This deviceK120680 Enspire Discectomy SystemSpine View, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K991794 | Endoscopic Spinal Access System | Endius, Inc. | 1999 | — |
| −6 | K021748 | Endius Atavi System | Endius, Inc. | 2002 | — |
| −5 | K053267 | Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −4 | K061345 | Modification to Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −3 | K081051 | Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope | Spine View, Inc. | 2008 | — |
| −2 | K090278 | Enspire Debrider System | Spine View, Inc. | 2009 | — |
| −1 | K110992 | Enspire Debrider System | Spine View, Inc. | 2011 | — |
| 0 (this device) | K120680 | Enspire Discectomy System | Spine View, Inc. | 2012 | — |
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 | 3 | 0 |
| 1995 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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? (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 |
|---|---|---|---|
| * | K110992 | Enspire Debrider SystemSummary page 1…E. Predicate Devices The modified enSpire Tm Discectomy System is substantially equivalent to the Spine View enSpire Tm Discectomy System cleared under K1 10992 on October 21, 2011. Appendix A, Page 1 of 4 === Page 2… | 2011 |
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 13 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 27 ancestors have a recall of any class.
- 2 other devices also cite its predicate K110992.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 enSpire Tm Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120680: Enspire Discectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120680
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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