# K222510: Blueprint Mixed Reality system

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Jan 20, 2023 after 154 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K911686 (1991). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173372: ExactechGPS Total Shoulder Application, Blue Ortho (2017) Summary page 4.

## Recalls of this device
- Mar 5, 2025 · Class II · Z-1541-2025: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system fro
- Mar 5, 2025 · Class II · Z-1538-2025: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system fro
- Mar 5, 2025 · Class II · Z-1539-2025: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system fro
- Mar 5, 2025 · Class II · Z-1540-2025: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system fro
- Mar 5, 2025 · Class II · Z-1542-2025: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system fro
- Mar 5, 2025 · Class II · Z-1534-2025: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system fro
- Mar 5, 2025 · Class II · Z-1535-2025: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system fro
- Mar 5, 2025 · Class II · Z-1537-2025: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system fro
- Mar 5, 2025 · Class II · Z-1536-2025: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system fro
- Dec 18, 2024 · Class II · Z-0846-2025: The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentia

## Indications for use
Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker’s FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Software. Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient’s anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.

Source page: https://510kreport.com/device/K222510
Methodology: https://510kreport.com/methodology