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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 / May 2026 / K253992

510(k) cleared

Veritas Reverse Total Shoulder System

Restor3D · May 7, 2026 · K253992

FDA cleared the Veritas Reverse Total Shoulder System from Restor3D on May 7, 2026 under K253992, a traditional 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 12, 2025. The decision came 146 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Restor3D has 2 other decisions in the tracker over the last 12 months: K260556 (Veritas Shoulder System), K252067 (Velora Acetabular System).

Questions & Answers

What did FDA clear under K253992?

K253992 is the FDA 510(k) for Veritas Reverse Total Shoulder System, submitted by Restor3D. FDA's decision date was May 7, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the Veritas Reverse Total Shoulder System?

Restor3D, based in Durham, NC, is the applicant of record for K253992.

How long did the K253992 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on May 7, 2026, 146 days later.

← All decisions in May 2026

Sources