Cleared Traditional

Velora Acetabular System

K252067 · Restor3D, Inc. · Orthopedic

Dec 2025

Decision

157d

Days

Class 2

Risk

About This 510(k) Submission

K252067 is an FDA 510(k) clearance for the Velora Acetabular System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on December 5, 2025, 157 days after receiving the submission on July 1, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K252067 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2025
Decision Date	December 05, 2025
Days to Decision	157 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358