Cleared Traditional

K250213 - OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)

Also marketed or referenced as:
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)

K250213 is an FDA 510(k) clearance for OptaBlate BVN Intraosseous Nerve Ablati..., manufactured by Stryker Instruments. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K250213 · Stryker Instruments · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
111d
Days
Class 2
Risk

K250213 is an FDA 510(k) clearance for the OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit). Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on May 15, 2025 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Instruments devices

FDA 510(k) Submission Details - K250213

510(k) Number K250213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2025
Decision Date May 15, 2025
Days to Decision 111 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 148d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXI Device Classification - Class 2, Special Controls

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
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 Neurology devices follow this clearance model.

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 53
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K250213.
STAR RF Ablation System
K251802 · Merit Medical Systems, Inc. · Feb 2026
OneRF Trigeminal Nerve Radiofrequency Probes
K251243 · Neuroone Medical Technologies Corp. · Aug 2025
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
K242841 · Abbott Medical · May 2025
RF Cannula
K241367 · Shanghai Samedical & Plastic Instruments Co., Ltd. · Jan 2025
Intracept Intraosseous Nerve Ablation System
K222281 · Relievant Medsystems, Inc. · Oct 2022
Intracept Intraosseous Nerve Ablation System
K213836 · Relievant Medsystems, Inc. · Mar 2022