# K072879: Innervue Diagnostic Scope System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Jan 14, 2008 after 97 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K833587 (1983). 21 ancestors in all.
30 later devices descend from it; 5 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043395: Smith & Nephew Videoarthroscope, Smith & Nephew, Inc. (2005) Summary page 1.
- K040604: Innervue Diagnostic Scope System, Arthrotek, Inc. (2004) Summary page 1.
- K030096: Video Arthroscope, Models AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW, Arthrex, Inc. (2003) Summary page 1.
- K002931: Metrx System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.
- K920800: Integrated Endoscopy System 1000, Biomet, Inc. (1992) Summary page 1.

## Most influential descendants
- K082293: Surgview Integrated Visualization System (2008), 21 descendants of its own
- K093717: C-Mor Visualization Device (2010), 16 descendants of its own
- K141119: Camera Enabled Probe (2014), 7 descendants of its own
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor (2011), 7 descendants of its own
- K101734: Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes (2010), 7 descendants of its own

## Recalls of this device
- Feb 10, 2011 · Not classified · Z-1588-2011: 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 t
- Feb 10, 2011 · Not classified · Z-1589-2011: 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 t

## Indications for use
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.

Source page: https://510kreport.com/device/K072879
Methodology: https://510kreport.com/methodology