Cleared Traditional

K222510 - Blueprint Mixed Reality system

K222510 is the FDA 510(k) clearance for Blueprint Mixed Reality system by Tornier S.A.S.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K222510 · Tornier S.A.S. · Orthopedic device
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Jan 2023
Decision
154d
Days
Class 2
Risk

K222510 is an FDA 510(k) clearance for the Blueprint Mixed Reality system. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Tornier S.A.S. (Montbonnot-Saint-Martin, FR). The FDA issued a Cleared decision on January 20, 2023 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tornier S.A.S. devices

Submission Details

510(k) Number K222510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2022
Decision Date January 20, 2023
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K222510.
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
K223767 · Stryker Leibinger GmbH & Co KG · Feb 2023
Naviswiss Knee
K223351 · Naviswiss AG · Jan 2023
360CAS
K223927 · Kico Knee Innovation Company Pty Limited · Jan 2023
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
K223108 · Medos International SARL · Jan 2023
Curiteva Navigation System
K223200 · Curiteva, Inc. · Jan 2023
VERTICALE® Navigation Instruments
K223649 · Silony Medical GmbH · Dec 2022