Cleared Traditional

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System

K241034 · Medacta International S.A. · Orthopedic

Jun 2024

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K241034 is an FDA 510(k) clearance for the Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System, a Bone Cement, Posterior Screw Augmentation (Class II — Special Controls, product code PML), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on June 12, 2024, 57 days after receiving the submission on April 16, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K241034 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2024
Decision Date	June 12, 2024
Days to Decision	57 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.