Cleared Traditional

K251737 - NextAR(TM) Shoulder Platform (FDA 510(k) Clearance)

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

K251737 · Medacta International S.A. · Orthopedic device
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Sep 2025
Decision
90d
Days
Class 2
Risk

K251737 is an FDA 510(k) clearance for the NextAR(TM) Shoulder Platform. Classified as Orthopedic Augmented Reality (product code SBF), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on September 4, 2025 after a review of 90 days - within the typical 510(k) review window.

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 Medacta International S.A. devices

Submission Details

510(k) Number K251737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2025
Decision Date September 04, 2025
Days to Decision 90 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 faster than avg
Panel avg: 122d · This submission: 90d
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

Medacta USA
Christopher Lussier

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 K251737.
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
OptiVu™ Shoulder
K252170 · Mr Surgical Solutions, LLC · Aug 2025