Cleared Traditional

SMR Stemless Anatomic

K221758 · Lima Corporate S.P.A. · Orthopedic

Mar 2023

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K221758 is an FDA 510(k) clearance for the SMR Stemless Anatomic, a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II — Special Controls, product code PKC), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on March 17, 2023, 274 days after receiving the submission on June 16, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K221758 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2022
Decision Date	March 17, 2023
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty