Cleared Traditional

K252788 - Tornier Perform Reversed Monopost Gleno...

K252788 is the FDA 510(k) clearance for Tornier Perform Reversed Monopost Gleno... by Tornier, Inc.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K252788 · Tornier, Inc. · Orthopedic device
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Jan 2026
Decision
128d
Days
Class 2
Risk

K252788 is an FDA 510(k) clearance for the Tornier Perform™ Reversed Monopost Glenoid (Perform Mono). Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 8, 2026 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tornier, Inc. devices

Submission Details

510(k) Number K252788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - PHX Shoulder Prosthesis, Reverse Configuration

All 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K252788.
N22 EZ Glenosphere
K252516 · Shoulder Innovations, Inc. · Jan 2026
AltiVate Reverse® ADLC Glenosphere
K252567 · Encore Medical, L.P. · Jan 2026
JARVIS Metaphyseal Stem
K254003 · FH Industrie · Jan 2026
MSS - Humeral reverse liners extension
K250338 · Medacta International S.A. · Oct 2025
JARVIS Diaphyseal Stem Standard
K253345 · FH Industrie · Oct 2025
Inset Reverse Total Shoulder System
K252221 · Shoulder Innovations, Inc. · Sep 2025