Cleared Traditional

K253158 - VyBrate™ VBR System

K253158 is an FDA 510(k) clearance for VyBrate VBR System, manufactured by Vy Spine, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K253158 · Vy Spine, LLC · Orthopedic device
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Jan 2026
Decision
103d
Days
Class 2
Risk

K253158 is an FDA 510(k) clearance for the VyBrate™ VBR System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Vy Spine, LLC (Bountiful, US). The FDA issued a Cleared decision on January 7, 2026 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Vy Spine, LLC devices

FDA 510(k) Submission Details - K253158

510(k) Number K253158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2025
Decision Date January 07, 2026
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 Peers - MQP Spinal Vertebral Body Replacement Device

All 236
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K253158.
Vertiwedge® Intraosseous System
K261810 · Foundation Surgical Group · Jul 2026
POSEIDON ST
K261031 · Signus Medinzintechnik GmbH · Jul 2026
Vertiwedge® Intraosseous System
K241468 · Foundation Surgical Group, Inc. · Nov 2024
KONG®-TL VBR System and KONG® C VBR System
K232790 · Icotec AG · Apr 2024
DOMINION Expandable Corpectomy System
K233359 · Astura Medical · Mar 2024
VerteLoc Spinal System
K231134 · Signature Orthopaedics Pty, Ltd. · Feb 2024