510(k) · Cleared
ClearedSmith & Nephew Arthroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HRX Arthroscope
Cleared on Oct 15, 2007 as substantially equivalent to K043395 (Smith & Nephew, Inc., 2005) after a 24-day review. Its family tree reaches back 4 generations to 1983. 8 later devices descend from it.
- Decided
- Oct 15, 2007
- Review
- 24 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K833587 (1983). 14 ancestors in all, the oldest K771218 (1978). 8 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 3 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 2 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 1 generation backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- This deviceK072675 Smith & Nephew ArthroscopeSmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
- Descendant · 2 generations on · 6 of its ownK153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS…Smith & Nephew · 2016
- Descendant · 3 generations on · 3 of its ownK190367 Smith & Nephew Tablet ApplicationSmith & Nephew · 2019
- Descendant · 4 generations on · 2 of its ownK192876 INTELLIO Tablet ApplicationSmith & Nephew · 2020
- Descendant · 5 generations on · 1 of its ownK203566 Tablet ApplicationSmith & Nephew · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC · 2010 · cites it directly7descendants
- K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew · 2016 · 2 generations on6descendants
- K190367Smith & Nephew Tablet ApplicationSmith & Nephew · 2019 · 3 generations on3descendants
- K192876INTELLIO Tablet ApplicationSmith & Nephew · 2020 · 4 generations on2descendants
- K203566Tablet ApplicationSmith & Nephew · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −3 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −2 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −1 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K072675 | Smith & Nephew Arthroscope | Smith & Nephew, Inc. | 2007 | — |
| +1 | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit… | Visionscope Technologies, LLC | 2010 | — |
| +2 | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head… | Smith & Nephew | 2016 | — |
| +3 | K190367 | Smith & Nephew Tablet Application | Smith & Nephew | 2019 | — |
| +4 | K192876 | INTELLIO Tablet Application | Smith & Nephew | 2020 | — |
| +5 | K203566 | Tablet Application | Smith & Nephew | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K043395 | Smith & Nephew VideoarthroscopeSummary page 1…Classification Name: Arthroscope D. Predicate Devices The current line of Smith & Nephew Arthroscopes serves as the predicate device for this submission (K043395). E. Description of Device Smith & Nephew Arthroscopes are reusable devices and are sterilized using a variety of steriliz… | 2005 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera… | 2010 | 7 |
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 24 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K101734 (Visionscope Technologies, LLC, 2010) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K043395.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 line of rigid Arthroscopes/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 Arthroscopes/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.
https://510kreport.com/device/K072675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072675: Smith & Nephew Arthroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072675
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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