# K153612: ArthrexVIP Web Portal

- Pathway: 510(k) (Traditional)
- Applicant: Custom Orthopaedic Solutions, Inc.
- Decided: Mar 15, 2016 after 89 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K911686 (1991). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151501: OrthoVis Web Portal, Custom Orthopaedic Solutions, Inc. (2015)

## Cited in the summary but kept off the family tree
- K151568: Arthrex OrthoVis Preoperative Plan, Custom Orthopaedic Solutions, Inc. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K151500: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS), Custom Orthopaedic Solutions (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The ArthrexVIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The ArthrexVIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers Apex, Arthrex Univers II, and Arthrex Univers Revers.

Source page: https://510kreport.com/device/K153612
Methodology: https://510kreport.com/methodology