Cleared Special

K250255 - xvision Spine system (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250255 · Augmedics, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
44d
Days
Class 2
Risk

K250255 is an FDA 510(k) clearance for the xvision Spine system. Classified as Orthopedic Augmented Reality (product code SBF), Class II - Special Controls.

Submitted by Augmedics, Ltd. (Yokneam Illit, IL). The FDA issued a Cleared decision on March 13, 2025 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Augmedics, Ltd. devices

Submission Details

510(k) Number K250255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2025
Decision Date March 13, 2025
Days to Decision 44 days
Submission Type Special
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
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

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

Hogan Lovells US LLP
Janice M. Hogan

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 K250255.
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