Cleared Traditional

SMR Hybrid Glenoid System

K231099 · Lima Corporate S.P.A. · Orthopedic

Dec 2023

Decision

247d

Days

Class 2

Risk

About This 510(k) Submission

K231099 is an FDA 510(k) clearance for the SMR Hybrid Glenoid 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 December 21, 2023, 247 days after receiving the submission on April 18, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K231099 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2023
Decision Date	December 21, 2023
Days to Decision	247 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