Blueprint Mixed Reality system

510(k) K222510

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK222510	Date20 Jan 2023Cleared	StatusActive

10 recalls · 10 ongoing · FDA

9 recalls, same reason
- Ongoing Z-1538-2025 FDA Class II initiated 5 Mar 2025
- Ongoing Z-1537-2025 FDA Class II initiated 5 Mar 2025
- Ongoing Z-1535-2025 FDA Class II initiated 5 Mar 2025
- Ongoing Z-1541-2025 FDA Class II initiated 5 Mar 2025
- Ongoing Z-1540-2025 FDA Class II initiated 5 Mar 2025
- Ongoing Z-1539-2025 FDA Class II initiated 5 Mar 2025
- Ongoing Z-1536-2025 FDA Class II initiated 5 Mar 2025
- Ongoing Z-1542-2025 FDA Class II initiated 5 Mar 2025
- Ongoing Z-1534-2025 FDA Class II initiated 5 Mar 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 from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Ongoing Z-0846-2025 FDA Class II initiated 18 Dec 2024
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 potentially prolonging surgery time or changing of surgical method from guided to conventional.

1 jurisdiction

United States — FDA 510(k) Active

510(k)