Cleared Traditional

Glenoid Reconstruction System ? Full Wedge Baseplate

K231911 · Medacta International S.A. · Orthopedic

Nov 2023

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K231911 is an FDA 510(k) clearance for the Glenoid Reconstruction System ? Full Wedge Baseplate, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on November 9, 2023, 133 days after receiving the submission on June 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K231911 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2023
Decision Date	November 09, 2023
Days to Decision	133 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.