# K230904: Arthrex Virtual Implant Positioning (VIP) System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 22, 2023 after 83 days
- Product code: QHE (Shoulder Arthroplasty Implantation System)
- 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: 14 generations back to K905070 (1991). 135 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222007: Arthrex Virtual Implant Positioning (VIP) System, Arthrex, Inc. (2023) Summary page 5.
- K213546: ExactechGPS Total Shoulder Application, Equinoxe Planning Software, Blue Ortho (2022) Summary page 5.

## Most influential descendants
- K241097: Arthrex Virtual Implant Positioning (VIP) System Software (2024), 0 descendants of its own

## Indications for use
The VIP 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 Arthrex technicians. The VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following implant lines: Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid), Univers Revers™ modular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with these implant lines. The OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning of glenoid and humeral components in total shoulder replacement, and intraoperative placement of the glenoid component in total shoulder replacement. The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates. The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

Source page: https://510kreport.com/device/K230904
Methodology: https://510kreport.com/methodology