Cleared Traditional

PERFORM Humeral System ? Stem

K201315 · Tornier, Inc. · Orthopedic

Sep 2020

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K201315 is an FDA 510(k) clearance for the PERFORM Humeral System ? Stem, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented (Class II — Special Controls, product code PAO), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 11, 2020, 116 days after receiving the submission on May 18, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K201315 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2020
Decision Date	September 11, 2020
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PAO — Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Total Shoulders Are Indicated For Arthritis (osteo-, Rheumatoid, Traumatic), Avascular Necrosis, Correction Of Functional Deformity, And Revision Procedures.