Cleared Traditional

MSS - Humeral reverse liners extension

K250338 · Medacta International S.A. · Orthopedic

Oct 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K250338 is an FDA 510(k) clearance for the MSS - Humeral reverse liners extension, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on October 31, 2025, 267 days after receiving the submission on February 6, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K250338 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2025
Decision Date	October 31, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PHX — Shoulder Prosthesis, Reverse Configuration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.