Cleared Traditional

PRIMA Humeral System; PRIMA TT Glenoid

K233712 · Lima Corporate S.P.A. · Orthopedic

Jan 2024

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K233712 is an FDA 510(k) clearance for the PRIMA Humeral System; 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. (Villanova Di San Daniele, IT). The FDA issued a Cleared decision on January 11, 2024, 52 days after receiving the submission on November 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K233712 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2023
Decision Date	January 11, 2024
Days to Decision	52 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