Cleared Traditional

SMR Reverse HP Shoulder System

K243826 · Lima Corporate S.P.A. · Orthopedic

Jul 2025

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K243826 is an FDA 510(k) clearance for the SMR Reverse HP Shoulder System, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Lima Corporate S.P.A. (Udine, IT). The FDA issued a Cleared decision on July 3, 2025, 203 days after receiving the submission on December 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K243826 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2024
Decision Date	July 03, 2025
Days to Decision	203 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.