Cleared Traditional

Tornier Perform? Reversed Monopost Glenoid (Perform Mono)

K252788 · Tornier, Inc. · Orthopedic

Jan 2026

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K252788 is an FDA 510(k) clearance for the Tornier Perform? Reversed Monopost Glenoid (Perform Mono), 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 January 8, 2026, 128 days after receiving the submission on September 2, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K252788 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2025
Decision Date	January 08, 2026
Days to Decision	128 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.