# K151501: OrthoVis Web Portal

- Pathway: 510(k) (Traditional)
- Applicant: Custom Orthopaedic Solutions, Inc.
- Decided: Oct 2, 2015 after 120 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: 8 generations back to K911686 (1991). 36 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133367: Orthovis Preoperative Plan, Custom Orthopaedic Solutions (2013) Summary page 5.
- K142072: Glenoid Intelligent Reusable Instrument System (Glenoid Iris), Custom Orthopaedic Solutions, Inc. (2014) Summary page 5.

## Most influential descendants
- K162697: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal (2017), 5 descendants of its own
- K222007: Arthrex Virtual Implant Positioning (VIP) System (2023), 3 descendants of its own
- K230904: Arthrex Virtual Implant Positioning (VIP) System (2023), 1 descendant of its own
- K241470: CORE Shoulder System (2025), 0 descendants of its own
- K241097: Arthrex Virtual Implant Positioning (VIP) System Software (2024), 0 descendants of its own

## Indications for use
The OrthoVis 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 pre-operative software for simulating / evaluating implant placement and surgical treatment options. The OrthoVis Web Portal is intended for use with the Glenoid Intelligent Reusable Instrument system and with the OrthoVis Preoperative Plan. It is also intended for use with the Arthrex and DePuy shoulder replacement implant systems listed below. * Arthrex Univers Apex * Arthrex Univers II * Arthrex Univers Revers * DePuy Global AP * DePuy Global StepTech * DePuy Delta Xtend Reverse The Glenoid Intelligent Reusable Instrument System (“Glenoid IRIS”) is a patient specific manual instrument system intended for use to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

Source page: https://510kreport.com/device/K151501
Methodology: https://510kreport.com/methodology