510(k) Report

510(k) · Cleared

Cleared

Spinevu Endoscopic Spine System (Sess)

K113362510(k) SpecialCleared Feb 10, 201287-day reviewClass II21 CFR 888.1100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spine View, Inc. · HRX Arthroscope

Cleared on Feb 10, 2012 as substantially equivalent to K081051 (Spine View, Inc., 2008) and 4 other predicates after an 87-day review. Its family tree reaches back 7 generations to 1999. 1 later device descends from it.

Decided
Feb 10, 2012
Review
87 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
5

Its longest line of descent runs back 7 generations to K991794 (1999). 31 ancestors in all, the oldest K844131 (1984). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 6 other ancestors2006: 2 other ancestors2002: 2 other ancestors2001: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor1994: 3 other ancestors1995: 1 other ancestor1993: 1 other ancestor1991: 2 other ancestors1990: 1 other ancestor1984: 1 other ancestor2012: 1 descendant clearedK991794 · Endoscopic Spinal Access System · Endius, Inc. · 1999K021748 · Endius Atavi System · Endius, Inc. · 2002×2: 2 generations cleared close together, K053267 (2006), K061345 (2006) K081051 · Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope · Spine View, Inc. · 2008K090278 · Enspire Debrider System · Spine View, Inc. · 2009K110992 · Enspire Debrider System · Spine View, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 9 other ancestors3 generations back: 5 other ancestors4 generations back: 8 other ancestors 1 generation forward: 1 descendant K110992 · Enspire Debrider System · Spine View, Inc. · 2011K090278 · Enspire Debrider System · Spine View, Inc. · 2009K081051 · Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope · Spine View, Inc. · 2008K061345 · Modification to Endius Atavi System · Endius, Inc. · 2006 · recalledK053267 · Endius Atavi System · Endius, Inc. · 2006 · recalledK021748 · Endius Atavi System · Endius, Inc. · 2002K991794 · Endoscopic Spinal Access System · Endius, Inc. · 1999−50
  1. Root · 7 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
  2. 6 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
  3. 5 generations backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
  4. 4 generations backK061345 Modification to Endius Atavi SystemEndius, Inc. · 2006 · Recalled
  5. 3 generations backK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
  6. 2 generations backK090278 Enspire Debrider SystemSpine View, Inc. · 2009
  7. 1 generation backK110992 Enspire Debrider SystemSpine View, Inc. · 2011
  8. This deviceK113362 Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012
  9. Descendant · cites it directly · 0 of its ownK121548 Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K121548Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K991794Endoscopic Spinal Access SystemEndius, Inc.1999—
−6K021748Endius Atavi SystemEndius, Inc.2002—
−5K053267Endius Atavi SystemEndius, Inc.20061
−4K061345Modification to Endius Atavi SystemEndius, Inc.20061
−3K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc.2008—
−2K090278Enspire Debrider SystemSpine View, Inc.2009—
−1K110992Enspire Debrider SystemSpine View, Inc.2011—
0 (this device)K113362Spinevu Endoscopic Spine System (Sess)Spine View, Inc.2012—
+1K121548Spinevu Endoscopic Spine System (Sess)Spine View, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199010
199120
199310
199430
199510
199610
199810
200060
200110
200220
200310
200510
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K113362, 1999–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K081051Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope
Summary page 1
…Predicate Device The modified SpineVu Endoscopic Spine System (SESS) is substantially equivalent to the Spine View SpineVu Endoscopic Spine System (SESS) (K081051), Spine View enSpire Discectomy System (K1 10992), Endius Atavi System (K061345), Richard Wolf Minimally Invasive S…
Spine View, Inc.2008—
*K110992Enspire Debrider System
Summary page 1
…c Spine System (SESS) is substantially equivalent to the Spine View SpineVu Endoscopic Spine System (SESS) (K081051), Spine View enSpire Discectomy System (K1 10992), Endius Atavi System (K061345), Richard Wolf Minimally Invasive Spinal Surgery Set (K994363), and Karl Storz Percutaneous…
Spine View, Inc.2011—
*K061345Modification to Endius Atavi System
Summary page 1
…tially equivalent to the Spine View SpineVu Endoscopic Spine System (SESS) (K081051), Spine View enSpire Discectomy System (K1 10992), Endius Atavi System (K061345), Richard Wolf Minimally Invasive Spinal Surgery Set (K994363), and Karl Storz Percutaneous Foraminoscopy Set (K001…
Endius, Inc.20061
*K994363Instruments for Minimally Invasive Spinal Surgery (Miss)
Summary page 1
…ystem (SESS) (K081051), Spine View enSpire Discectomy System (K1 10992), Endius Atavi System (K061345), Richard Wolf Minimally Invasive Spinal Surgery Set (K994363), and Karl Storz Percutaneous Foraminoscopy Set (K001 918). G. Device Description The SpineVu Endloscopic Spin…
Richard Wolf Medical Instruments Corp.2000—
*K001918Ksea Percutaneous Foraminoscopy Set
Summary page 1
…tem (K1 10992), Endius Atavi System (K061345), Richard Wolf Minimally Invasive Spinal Surgery Set (K994363), and Karl Storz Percutaneous Foraminoscopy Set (K001 918). G. Device Description The SpineVu Endloscopic Spine System (SESS) is a collection of arthroscopic surgical a…
KARL STORZ Endoscopy-America, Inc.2000—

Also cleared against K081051: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121548Spinevu Endoscopic Spine System (Sess)Spine View, Inc.20120

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 31 ancestors have a recall of any class.
  • Of its descendants, K121548 (Spine View, Inc., 2012) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K081051.

How does its category compare?

All HRX devices

HRX 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

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

What is it indicated for?

surgical accessories are indicated for facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Indications for use as stated in the FDA summary.

Also cleared against K081051

3 other devices cite the same predicate.

  • K122134Flexlite CameraSpine View, Inc. · 2012
  • K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video…Vision-Sciences, Inc. · 2011
  • K090278Enspire Debrider SystemSpine View, Inc. · 2009

More from Spine View, Inc.

9 FDA decisions under this applicant name. See the company

  • K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc. · 2016
  • K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc. · 2016
  • K122134Flexlite CameraSpine View, Inc. · 2012
  • K121548Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012
  • K120680Enspire Discectomy SystemSpine View, Inc. · 2012

Recent decisions in HRX

The HRX category page

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026

https://510kreport.com/device/K113362 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113362: 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/K113362

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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