Cleared Traditional

SMR Shoulder System

K223876 · Lima Corporate S.P.A. · Orthopedic

Feb 2023

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K223876 is an FDA 510(k) clearance for the SMR Shoulder System, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code MBF), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on February 3, 2023, 42 days after receiving the submission on December 23, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K223876 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2022
Decision Date	February 03, 2023
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3670