Cleared Traditional

PRIMA Humeral System and SMR Glenosphere ?42

K212800 · Lima Corporate S.P.A. · Orthopedic

Feb 2022

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K212800 is an FDA 510(k) clearance for the PRIMA Humeral System and SMR Glenosphere ?42, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on February 25, 2022, 176 days after receiving the submission on September 2, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K212800 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2021
Decision Date	February 25, 2022
Days to Decision	176 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.