Cleared Traditional

Atlas Spine HiRISE? Expandable Cervical Corpectomy System

K252560 · Atlas Spine, Inc. · Orthopedic

Nov 2025

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K252560 is an FDA 510(k) clearance for the Atlas Spine HiRISE? Expandable Cervical Corpectomy System, a Spinal Vertebral Body Replacement Device - Cervical (Class II — Special Controls, product code PLR), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on November 10, 2025, 89 days after receiving the submission on August 13, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K252560 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2025
Decision Date	November 10, 2025
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	PLR — Spinal Vertebral Body Replacement Device - Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3060
Definition	Vertebral Body Replacement In The Cervical Spine.