510(k) · Cleared
ClearedSpinevu Endoscopic Spine System (Sess)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine View, Inc. · HRX Arthroscope
Cleared on Aug 16, 2012 as substantially equivalent to K113362 (Spine View, Inc., 2012) and 1 other predicate after an 83-day review. Its family tree reaches back 8 generations to 1999.
- Decided
- Aug 16, 2012
- Review
- 83 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K991794 (1999). 32 ancestors in all, the oldest K844131 (1984). No later device cites it as a predicate yet.
- Root · 8 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
- 7 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
- 6 generations backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 5 generations backK061345 Modification to Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 4 generations backK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
- 3 generations backK090278 Enspire Debrider SystemSpine View, Inc. · 2009
- 2 generations backK110992 Enspire Debrider SystemSpine View, Inc. · 2011
- 1 generation backK113362 Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012
- This deviceK121548 Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K991794 | Endoscopic Spinal Access System | Endius, Inc. | 1999 | — |
| −7 | K021748 | Endius Atavi System | Endius, Inc. | 2002 | — |
| −6 | K053267 | Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −5 | K061345 | Modification to Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −4 | K081051 | Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope | Spine View, Inc. | 2008 | — |
| −3 | K090278 | Enspire Debrider System | Spine View, Inc. | 2009 | — |
| −2 | K110992 | Enspire Debrider System | Spine View, Inc. | 2011 | — |
| −1 | K113362 | Spinevu Endoscopic Spine System (Sess) | Spine View, Inc. | 2012 | — |
| 0 (this device) | K121548 | Spinevu Endoscopic Spine System (Sess) | 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 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 6 | 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? (4)
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 |
|---|---|---|---|
| * | K113362 | Spinevu Endoscopic Spine System (Sess)Summary page 1…The modified Minimally Invasive Surgical (MIS) Decompression System is substantially equivalent to the Spine View SpineVu Endoscopic Spine System (SESS) (K1 13362 and K08151) and predicate cutting instruments offered as part of the Richard Wolf Medical Instrumnents Corp. Mini… | 2012 |
| Kept off the family tree | K081511 | FDA’s K081511 is 2.0 PK Suture Anchor T, 2.0 PK Suture Anchor S Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K994363 | Instruments for Minimally Invasive Spinal Surgery (Miss)Summary page 1…13362 and K08151) and predicate cutting instruments offered as part of the Richard Wolf Medical Instrumnents Corp. Minimally Invasive Spinal Surgery Set (K994363) and several Class 1. orthopedic manual surgical instruments, including the Joimax EndoReamer and EndoChisel Asse… | 2000 |
| * | — | Joimax EndoReamer and EndoChisel Assembly Named without a submission number |
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 32 ancestors have a recall of any class.
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 Spine View Minimally Invasive Surgical (MIS) Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121548: Spinevu Endoscopic Spine System (Sess).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121548
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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