Cleared Traditional

K250108 - OptiVu™ Shoulder (FDA 510(k) Clearance)

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

K250108 · Mr Surgical Solutions, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
174d
Days
Class 2
Risk

K250108 is an FDA 510(k) clearance for the OptiVu™ Shoulder. Classified as Orthopedic Augmented Reality (product code SBF), Class II - Special Controls.

Submitted by Mr Surgical Solutions, LLC (Conshohocken, US). The FDA issued a Cleared decision on July 9, 2025 after a review of 174 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 Mr Surgical Solutions, LLC devices

Submission Details

510(k) Number K250108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2025
Decision Date July 09, 2025
Days to Decision 174 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
52d slower than avg
Panel avg: 122d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SBF Orthopedic Augmented Reality
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition An Orthopedic Augmented Reality Device Provides Visual Guidance During Orthopedic Procedures, Where The Use Of Stereotaxic Navigation Is Utilized. Visual Guidance Is Displayed As “augmented Reality” Stereoscopic Images To Intraoperatively Augment The User’s Field Of View.
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

Jalex Medical
Kyle Kovach

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 - SBF Orthopedic Augmented Reality

All 41
Devices cleared under the same product code (SBF) and FDA review panel - the closest regulatory comparables to K250108.
Knee+
K253805 · Pixee Medical S.A.S. · Apr 2026
NextAR Hip Platform
K252847 · Medacta International S.A. · Jan 2026
xvision Spine system
K251639 · Augmedics, Ltd. · Oct 2025
SpineAR SNAP (SyncAR Spine)
K252054 · Surgical Theater, Inc. · Sep 2025
OptiVu™ Shoulder
K252530 · Mr Surgical Solutions, LLC · Sep 2025
NextAR(TM) Shoulder Platform
K251737 · Medacta International S.A. · Sep 2025