510(k) Report

510(k) · Cleared

Cleared

Smith & Nephew Videoarthroscope

K043395510(k) TraditionalCleared Jan 12, 200533-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

Smith & Nephew, Inc. · HRX Arthroscope

Cleared on Jan 12, 2005 as substantially equivalent to K971253 (Smith & Nephew, Inc., 1997) after a 33-day review. Its family tree reaches back 3 generations to 1983. 32 later devices descend from it.

Decided
Jan 12, 2005
Review
33 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K833587 (1983). 13 ancestors in all, the oldest K771218 (1978). 32 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor1982: 1 other ancestor1978: 1 other ancestor2011: 1 descendant cleared2007: 1 descendant cleared2010: 2 descendants cleared2008: 2 descendants cleared2012: 2 descendants cleared2015: 4 descendants cleared2014: 2 descendants cleared2018: 2 descendants cleared2016: 2 descendants cleared2021: 3 descendants cleared2026: 2 descendants cleared2017: 1 descendant cleared2019: 3 descendants cleared2024: 2 descendants cleared2020: 1 descendant cleared2022: 2 descendants clearedK833587 · Disposable Arthroscopy Blade · Dyonics, Inc. · 1983K900070 · Modified Uses of the Arthroscopic Surgical System · Dyonics, Inc. · 1990K971253 · Various Arthroscopes, Endoscopic Blades, Manual Instruments · Smith & Nephew, Inc. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 10 other ancestors 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 7 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K971253 · Various Arthroscopes, Endoscopic Blades, Manual Instruments · Smith & Nephew, Inc. · 1997K900070 · Modified Uses of the Arthroscopic Surgical System · Dyonics, Inc. · 1990K833587 · Disposable Arthroscopy Blade · Dyonics, Inc. · 19830+5
  1. Root · 3 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
  2. 2 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
  3. 1 generation backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
  4. This deviceK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
  5. Descendant · cites it directly · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
  6. Descendant · cites it directly · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
  7. Descendant · cites it directly · 16 of its ownK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
  8. Descendant · cites it directly · 8 of its ownK072675 Smith & Nephew ArthroscopeSmith & Nephew, Inc. · 2007
  9. Descendant · 2 generations on · 7 of its ownK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22010: 22011: 12012: 22014: 22015: 42016: 22017: 12018: 22019: 32020: 12021: 32022: 22024: 22026: 2
2007high 4 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 32 · See all
  • K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · cites it directly30descendants
  • K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008 · cites it directly21descendants
  • K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010 · cites it directly16descendants
  • K072675Smith & Nephew ArthroscopeSmith & Nephew, Inc. · 2007 · cites it directly8descendants
  • K141119Camera Enabled ProbeTrice Medical, Inc. · 2014 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K833587Disposable Arthroscopy BladeDyonics, Inc.1983—
−2K900070Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc.1990—
−1K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc.1997—
0 (this device)K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc.2005—
+1K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.20082
+1K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC2008—
+1K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc.2010—
+1K072675Smith & Nephew ArthroscopeSmith & Nephew, Inc.2007—
+2K141119Camera Enabled ProbeTrice Medical, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198210
198810
199010
199110
199210
199410
199520
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201020
201110
201220
201420
201540
201620
201710
201820
201930
202010
202130
202220
202420
202620
FIG. 1 — Lineage of K043395, 1983–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K971253Various Arthroscopes, Endoscopic Blades, Manual Instruments
Summary page 1
…ope Classification Name: Arthroscope D. Predicate Devices The current Smith & Nephew VideoArthroscope serves as the predicate device for this submission (K971253). E. Description of Device The Smith & Nephew VideoArthroscope is a reusable VideoArthroscope. The proposed device i…
Smith & Nephew, Inc.1997—

Also cleared against K971253: 4 other devices →

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.200830
K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC200821
K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc.201016
K072675Smith & Nephew ArthroscopeSmith & Nephew, Inc.20078
K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117

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 22 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
  • None of the 13 ancestors has a recall.
  • Of its descendants, K072879 (Biomet Orthopedics, Inc., 2008) has gone furthest, with 30 descendants of its own.
  • 4 other devices also cite its predicate K971253.

How does its category compare?

All HRX devices

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

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 Smith & Nephew VideoArthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx.

In addition, the Smith & Nephew 4 mm diameter rigid VideoArthroscopes/ENT Endoscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Indications for use as stated in the FDA summary.

Also cleared against K971253

4 other devices cite the same predicate.

  • K080560Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008
  • K012652Reprocessed Dyonics Arthroscopic BursAlliance Medical Corp. · 20017 recalls
  • K012611Reprocessed Dyonics Arthroscopic ShaversAlliance Medical, Inc. · 20017 recalls
  • K982375Stryker Hip Arthoroscopy SetStryker Endoscopy · 1998

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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/K043395 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043395: Smith & Nephew Videoarthroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043395

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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