# K162697: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal

- Pathway: 510(k) (Traditional)
- Applicant: Custom Orthopaedic Solutions, Inc.
- Decided: Feb 10, 2017 after 136 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- 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). 39 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142072: Glenoid Intelligent Reusable Instrument System (Glenoid Iris), Custom Orthopaedic Solutions, Inc. (2014) Summary page 8.
- K133367: Orthovis Preoperative Plan, Custom Orthopaedic Solutions (2013) Summary page 8.
- K151501: OrthoVis Web Portal, Custom Orthopaedic Solutions, Inc. (2015) Summary page 8.
- K151568: Arthrex OrthoVis Preoperative Plan, Custom Orthopaedic Solutions, Inc. (2015) Summary page 7.
- K151500: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS), Custom Orthopaedic Solutions (2015) Summary page 7.

## Most influential descendants
- 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
- K193523: ArthrexVIP Web Portal (2020), 0 descendants of its own

## Indications for use
The Glenoid Intelligent Reusable Instrument System (“Glenoid IRIS™) is a patient specific manual instrument system intended 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. The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component. The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems. The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component. The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems. The Glenoid Intelligent Reusable Instrument System (“Glenoid IRIS™) is a patient specific manual instrument system intended 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. The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component. The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems. 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 II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.

Source page: https://510kreport.com/device/K162697
Methodology: https://510kreport.com/methodology