510(k) Report

510(k) · Cleared

Cleared

Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope

K081051510(k) TraditionalCleared Aug 7, 2008115-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 Aug 7, 2008 as substantially equivalent to K000046 (Richard Wolf Medical Instruments Corp., 2000) and 4 other predicates after a 115-day review. Its family tree reaches back 4 generations to 1999. 16 later devices descend from it.

Decided
Aug 7, 2008
Review
115 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K991794 (1999). 15 ancestors in all, the oldest K941967 (1994). 16 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2001: 1 other ancestor2000: 4 other ancestors2005: 1 other ancestor2002: 1 other ancestor1994: 2 other ancestors2011: 2 descendants cleared2012: 6 descendants cleared2009: 1 descendant cleared2018: 1 descendant cleared2015: 3 descendants cleared2017: 1 descendant cleared2013: 2 descendants clearedK991794 · Endoscopic Spinal Access System · Endius, Inc. · 1999K021748 · Endius Atavi System · Endius, Inc. · 2002K053267 · Endius Atavi System · Endius, Inc. · 2006 · recalledK061345 · Modification to Endius Atavi System · Endius, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K061345 · 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. · 19990
  1. Root · 4 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
  2. 3 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
  3. 2 generations backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
  4. 1 generation backK061345 Modification to Endius Atavi SystemEndius, Inc. · 2006 · Recalled
  5. This deviceK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
  6. Descendant · cites it directly · 7 of its ownK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
  7. Descendant · cites it directly · 7 of its ownK090278 Enspire Debrider SystemSpine View, Inc. · 2009
  8. Descendant · 2 generations on · 6 of its ownK110992 Enspire Debrider SystemSpine View, Inc. · 2011
  9. Descendant · 3 generations on · 2 of its ownK120553 ESPINNlt Spine, Ltd. · 2012
  10. Descendant · 2 generations on · 1 of its ownK150776 Medrobotics Flex SystemMedrobotics Corporation · 2015

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2009: 12011: 22012: 62013: 22015: 32017: 12018: 1
2009high 6 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 16 · See all
  • K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc. · 2011 · cites it directly7descendants
  • K090278Enspire Debrider SystemSpine View, Inc. · 2009 · cites it directly7descendants
  • K110992Enspire Debrider SystemSpine View, Inc. · 2011 · 2 generations on6descendants
  • K120553ESPINNlt Spine, Ltd. · 2012 · 3 generations on2descendants
  • K150776Medrobotics Flex SystemMedrobotics Corporation · 2015 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K991794Endoscopic Spinal Access SystemEndius, Inc.1999—
−3K021748Endius Atavi SystemEndius, Inc.2002—
−2K053267Endius Atavi SystemEndius, Inc.20061
−1K061345Modification to Endius Atavi SystemEndius, Inc.20061
0 (this device)K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc.2008—
+1K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc.2011—
+1K090278Enspire Debrider SystemSpine View, Inc.2009—
+2K110992Enspire Debrider SystemSpine View, Inc.2011—
+3K120553ESPINNlt Spine, Ltd.2012—
+2K150776Medrobotics Flex SystemMedrobotics Corporation2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
200040
200110
200210
200510
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201120
201260
201320
201530
201710
201810
FIG. 1 — Lineage of K081051, 1999–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
*K000046Knight Endoscopic Spine System (Kess)
Summary page 1
…icate Device R ichardWlf Ellman Atr~r Manufacturers: trMedicalenaioa K#s K000046 K052241 K010811 Arthroscope & Arthros…
Richard Wolf Medical Instruments Corp.2000—
*K052241Disc-FX System
Summary page 1
…R ichardWlf Ellman Atr~r Manufacturers: trMedicalenaioa K#s K000046 K052241 K010811 Arthroscope & Arthroscope & Predicate…
Ellman International, Inc.2006—
*K010811Perc-D Spinewand
Summary page 1
…Ellman Atr~r Manufacturers: trMedicalenaioa K#s K000046 K052241 K010811 Arthroscope & Arthroscope & Predicate Device Arthroscope…
Arthrocare Corp.2001—
*K061246Endoscopic Spine System
Summary page 2
…edicate Devices: Interchangeable Atavi System Spine System Predicate Device Arthro Kinetics Endius Manufacturers: K#s K061246 K061345 Predicate Device Arthroscope & Arthroscope & Common Name: accessories accessories…
Arthro Kinetics, Inc.2006—
*K061345Modification to Endius Atavi System
Summary page 2
…nterchangeable Atavi System Spine System Predicate Device Arthro Kinetics Endius Manufacturers: K#s K061246 K061345 Predicate Device Arthroscope & Arthroscope & Common Name: accessories accessories 21CFR888…
Endius, Inc.20061

What descends from it? (16)

See all 16

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117
K090278Enspire Debrider SystemSpine View, Inc.20097
K113362Spinevu Endoscopic Spine System (Sess)Spine View, Inc.20121
K122134Flexlite CameraSpine 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 9 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
  • 2 of the 15 ancestors have a recall of any class.
  • Of its descendants, K102733 (Vision-Sciences, Inc., 2011) has gone furthest, with 7 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

The SpineVu Endoscopic Spine System (SESSTM) and SpineVu MiniScope are indicated for use for endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and are accessorized with surgical and coagulation tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Indications for use as stated in the FDA summary.

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/K081051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081051: Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081051

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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