Cleared Traditional

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

K252352 · Lima Corporate S.P.A. · Orthopedic

Jan 2026

Decision

177d

Days

Class 2

Risk

About This 510(k) Submission

K252352 is an FDA 510(k) clearance for the SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Lima Corporate S.P.A. (Villanova Di San Daniele, IT). The FDA issued a Cleared decision on January 22, 2026, 177 days after receiving the submission on July 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K252352 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2025
Decision Date	January 22, 2026
Days to Decision	177 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.