Cleared Traditional

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

K252885 · Astura Medical · Orthopedic

Jan 2026

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K252885 is an FDA 510(k) clearance for the OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System, a Bone Cement, Posterior Screw Augmentation (Class II — Special Controls, product code PML), submitted by Astura Medical (Irving, US). The FDA issued a Cleared decision on January 22, 2026, 134 days after receiving the submission on September 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K252885 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2025
Decision Date	January 22, 2026
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PML — Bone Cement, Posterior Screw Augmentation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3027
Definition	The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.