# K133367: Orthovis Preoperative Plan

- Pathway: 510(k) (Traditional)
- Applicant: Custom Orthopaedic Solutions
- Decided: Dec 20, 2013 after 49 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: 7 generations back to K911686 (1991). 34 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123122: Glenoid Intelligent Reusable Instrument System (Glenoid Iris), Cleveland Clinic (2013) Summary page 2.
- K073449: Surgicase, Materialise NV (2008) Summary page 5.

## Most influential descendants
- K151568: Arthrex OrthoVis Preoperative Plan (2015), 20 descendants of its own
- 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
- K151501: OrthoVis Web Portal (2015), 7 descendants of its own

## Indications for use
The OrthoVis Preoperative Plan is a preoperative plan document created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The OrthoVis Software and resulting Preoperative Plan is indicated for use with the DePuy Global APTM Shoulder glenoid. Global Shoulder StepTechrM Anchor Peg glenoid, or Delta XtendTM Reverse Shoulder metaglene components. The indications for use of the DePuy shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in 510(k) K 123 122.

Source page: https://510kreport.com/device/K133367
Methodology: https://510kreport.com/methodology