510(k) · Cleared
Recalled · 2011Innervue Diagnostic Scope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · HRX Arthroscope
Cleared on Jan 14, 2008 as substantially equivalent to K043395 (Smith & Nephew, Inc., 2005) and 4 other predicates after a 97-day review. Its family tree reaches back 4 generations to 1983. 30 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 14, 2008
- Review
- 97 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 4 generations to K833587 (1983). 21 ancestors in all, the oldest K771218 (1978). 30 later devices descend from it, 5 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 deviceK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008
- Descendant · cites it directly · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- Descendant · cites it directly · 16 of its ownK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008 · cites it directly21descendants
- K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010 · cites it directly16descendants
- K141119Camera Enabled ProbeTrice Medical, Inc. · 2014 · 2 generations on7descendants
- K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc. · 2011 · cites it directly7descendants
- K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC · 2010 · cites it directly7descendants
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) | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | — |
| +1 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| +1 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| +2 | K141119 | Camera Enabled Probe | Trice Medical, Inc. | 2014 | — |
| +1 | K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology… | Vision-Sciences, Inc. | 2011 | — |
| +1 | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit… | Visionscope Technologies, LLC | 2010 | — |
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 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043395 | Smith & Nephew VideoarthroscopeSummary page 1…Endoscope, 21 CFR §876.1500, GO Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Video Arthroscope K043395 Smith & Nephew InnerVue tM Diagnostic Scope System K040604 Arthrotek, Inc. (Biomet Sports Medicine) Arthrex Arthroscope… | 2005 |
| * | K040604 | Innervue Diagnostic Scope SystemSummary page 1…ly Marketed Devices To Which Substantial Equivalence Is Claimed: Video Arthroscope K043395 Smith & Nephew InnerVue tM Diagnostic Scope System K040604 Arthrotek, Inc. (Biomet Sports Medicine) Arthrex Arthroscopes K030096 Arthrex, Inc. METRX TM System… | 2004 |
| * | K030096 | Video Arthroscope, Models AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30…Summary page 1…K043395 Smith & Nephew InnerVue tM Diagnostic Scope System K040604 Arthrotek, Inc. (Biomet Sports Medicine) Arthrex Arthroscopes K030096 Arthrex, Inc. METRX TM System K002931 Medtronic Sofamor Danek Integrated Endoscopy System K… | 2003 |
| * | K002931 | Metrx SystemSummary page 1…tic Scope System K040604 Arthrotek, Inc. (Biomet Sports Medicine) Arthrex Arthroscopes K030096 Arthrex, Inc. METRX TM System K002931 Medtronic Sofamor Danek Integrated Endoscopy System K920800 Integrated Endoscopy System Device Description: The Inn… | 2000 |
| * | K920800 | Integrated Endoscopy System 1000Summary page 1…threx Arthroscopes K030096 Arthrex, Inc. METRX TM System K002931 Medtronic Sofamor Danek Integrated Endoscopy System K920800 Integrated Endoscopy System Device Description: The InnerVue MT Diagnostic Scope System consists of five (5) main parts: hardwar… | 1992 |
What descends from it? (30)
See all 305 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082293 | Surgview Integrated Visualization System | 2008 | 21 |
| K093717 | C-Mor Visualization Device | 2010 | 16 |
| K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences… | 2011 | 7 |
| K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera… | 2010 | 7 |
| K123359 | OVS1 Video System | 2012 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2011 | Not classified | Z-1588-2011 | Process design | The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand piece. This condition… |
| Feb 10, 2011 | Not classified | Z-1589-2011 | Process design | The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand piece. This condition… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K082293 (Biovision Technologies, LLC, 2008) has gone furthest, with 21 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. 2008, 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 InnerVueTM Diagnostic Scope System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072879: Innervue Diagnostic Scope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072879
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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