# K241097: Arthrex Virtual Implant Positioning (VIP) System Software

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 2, 2024 after 163 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: 15 generations back to K905070 (1991). 145 ancestors in all.
No later device cites it as a predicate yet.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230904: Arthrex Virtual Implant Positioning (VIP) System, Arthrex, Inc. (2023) Summary page 5.
- K232265: BLUEPRINT™ Patient Specific Instrumentation, Tornier S.A.S. (2024) Summary page 5.

## Indications for use
VIP Web Portal: 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 T II and UniversTM Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers ReversT" baseplate component (Universal Glenoid), Univers ReversTM modular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with these implant lines. OrthoVis Preoperative Plan: 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 TM 11 and Univers T Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers ReversTM baseplate component (Universal Glenoid) and Univers ReversTr modular glenoid system (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers ReversTr 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/K241097
Methodology: https://510kreport.com/methodology