Cleared Traditional

Tornier Perform? Patient-Matched Primary Reversed Glenoid and BLUEPRINT? Patient Specific Instrumentation

K211359 · Tornier, Inc. · Orthopedic

Nov 2021

Decision

193d

Days

Class 2

Risk

About This 510(k) Submission

K211359 is an FDA 510(k) clearance for the Tornier Perform? Patient-Matched Primary Reversed Glenoid and BLUEPRINT? Patient Specific Instrumentation, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on November 12, 2021, 193 days after receiving the submission on May 3, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K211359 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2021
Decision Date	November 12, 2021
Days to Decision	193 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PHX — Shoulder Prosthesis, Reverse Configuration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.