Cleared Traditional

K252058 - ROSA Knee System with UltraSound Imaging Platform (USIP) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252058 · Balmoral Medical, LLC · Orthopedic device
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Feb 2026
Decision
220d
Days
Class 2
Risk

K252058 is an FDA 510(k) clearance for the ROSA Knee System with UltraSound Imaging Platform (USIP). Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Balmoral Medical, LLC (Rosemont, US). The FDA issued a Cleared decision on February 6, 2026 after a review of 220 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 Balmoral Medical, LLC devices

Submission Details

510(k) Number K252058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2025
Decision Date February 06, 2026
Days to Decision 220 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
98d slower than avg
Panel avg: 122d · This submission: 220d
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 Consultant

Qserve Group, Us, Inc.
Lorry Weaver

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 422
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K252058.
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · Foundation Surgical Group, Inc. · Apr 2026
SPINEART Navigation Instrument System
K254158 · Spineart SA · Apr 2026
SYMPHONY Navigation Ready Instruments
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REAL INTELLIGENCE™ CORI™
K260601 · Blue Belt Technologies, Inc. · Mar 2026
CUVIS-joint (CJ150)
K252037 · Curexo, Inc. · Mar 2026
TiLink-L Navigation Instruments
K253604 · SurGenTec, LLC · Mar 2026