# K151568: Arthrex OrthoVis Preoperative Plan

- Pathway: 510(k) (Traditional)
- Applicant: Custom Orthopaedic Solutions, Inc.
- Decided: Jul 31, 2015 after 51 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). 35 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 56 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 4.

## Most influential descendants
- K162567: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (2017), 15 descendants of its own
- K173372: ExactechGPS Total Shoulder Application (2017), 14 descendants of its own
- K213546: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (2022), 8 descendants of its own
- K210153: NextAR RSA Platform (2021), 5 descendants of its own
- 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

## Indications for use
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 Preoperative Plan is indicated for use in planning the central glenoid guide pin for the Arthrex Univers™ II and Univers™ Apex Keeled glenoid component, Univers™ II and Univers™ Apex Pegged glenoid component, and the Univers Revers™ Baseplate. 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.

Source page: https://510kreport.com/device/K151568
Methodology: https://510kreport.com/methodology