Cleared Traditional

Tornier Perform Humeral System ? Stemless

K220418 · Tornier, Inc. · Orthopedic

Sep 2022

Decision

212d

Days

Class 2

Risk

About This 510(k) Submission

K220418 is an FDA 510(k) clearance for the Tornier Perform Humeral System ? Stemless, a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II — Special Controls, product code PKC), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 14, 2022, 212 days after receiving the submission on February 14, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K220418 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2022
Decision Date	September 14, 2022
Days to Decision	212 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