Cleared Traditional

PRIMA TT Glenoid

K222427 · Lima Corporate S.P.A. · Orthopedic

Oct 2022

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K222427 is an FDA 510(k) clearance for the PRIMA TT Glenoid, 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 October 6, 2022, 56 days after receiving the submission on August 11, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K222427 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2022
Decision Date	October 06, 2022
Days to Decision	56 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