WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K253158

510(k) cleared

VyBrate VBR System

Vy Spine, LLC · Jan 7, 2026 · K253158

FDA cleared the VyBrate VBR System from Vy Spine, LLC on Jan 7, 2026 under K253158, a traditional 510(k). The device falls under product code MQP, Spinal Vertebral Body Replacement Device, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 26, 2025. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Vy Spine, LLC has 2 other decisions in the tracker over the last 12 months: K260697 (VyPlate Anterior Cervical Plate System), K253432 (DiversiVy Facet Screw System).

Questions & Answers

What did FDA clear under K253158?

K253158 is the FDA 510(k) for VyBrate VBR System, submitted by Vy Spine, LLC. FDA's decision date was Jan 7, 2026, under product code MQP (Spinal Vertebral Body Replacement Device).

Who makes the VyBrate VBR System?

Vy Spine, LLC, based in Bountiful, UT, is the applicant of record for K253158.

How long did the K253158 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jan 7, 2026, 103 days later.

← All decisions in January 2026

Sources