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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 / December 2025 / K252067

510(k) cleared

Velora Acetabular System

Restor3D, Inc. · Dec 5, 2025 · K252067

FDA cleared the Velora Acetabular System from Restor3D, Inc. on Dec 5, 2025 under K252067, a traditional 510(k). The device falls under product code LPH, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, regulated at 21 CFR 888.3358 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 1, 2025. The decision came 157 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Restor3D, Inc. has 2 other decisions in the tracker over the last 12 months: K260556 (Veritas Shoulder System), K253992 (Veritas Reverse Total Shoulder System).

Questions & Answers

What did FDA clear under K252067?

K252067 is the FDA 510(k) for Velora Acetabular System, submitted by Restor3D, Inc.. FDA's decision date was Dec 5, 2025, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the Velora Acetabular System?

Restor3D, Inc., based in Durham, NC, is the applicant of record for K252067.

How long did the K252067 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Dec 5, 2025, 157 days later.

← All decisions in December 2025

Sources