Cleared Traditional

xvision Spine system (XVS) (K211188) - FDA 510(k) Clearance

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

K211188 · Augmedics, Ltd. · Orthopedic device
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Jul 2021
Decision
90d
Days
Class 2
Risk

K211188 is an FDA 510(k) clearance for the xvision Spine system (XVS). 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 July 19, 2021 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 Augmedics, Ltd. devices

Submission Details

510(k) Number K211188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2021
Decision Date July 19, 2021
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

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 K211188.
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K213751 · Medacta International S.A. · Mar 2022
ARAI Surgical Navigation System
K211254 · Surgalign Spine Technologies · Jan 2022
NextAR™ Spine Platform
K210859 · Medacta International S.A. · Nov 2021
NextAR RSA Platform
K210153 · Medacta International S.A. · May 2021
Knee+
K202750 · Pixee Medical · Apr 2021
NextAR TKA Platform
K202152 · Medacta International S.A. · Oct 2020