Cleared Special

K213124 - Tomier Perform Reversed Glenoid Cannula...

K213124 is the FDA 510(k) clearance for Tomier Perform Reversed Glenoid Cannula... by Tornier, Inc.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K213124 · Tornier, Inc. · Orthopedic device
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Oct 2021
Decision
29d
Days
Class 2
Risk

K213124 is an FDA 510(k) clearance for the Tomier Perform™ Reversed Glenoid Cannulated Glenospheres. 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 October 26, 2021 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tornier, Inc. devices

Submission Details

510(k) Number K213124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date October 26, 2021
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K213124.
Arthrex Modular Glenoid System-Titanium Glenosphere
K212415 · Arthrex, Inc. · Nov 2021
Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
K211359 · Tornier, Inc. · Nov 2021
Comprehensive® Convertible Glenoid - Vivacit-E Liner
K211729 · Biomet Manufacturing Corp · Nov 2021
GLOBAL UNITE™ Platform Shoulder System
K212710 · Depuy Ireland UC · Sep 2021
Univers Revers Modular Glenoid System, Standard Augment Baseplates
K211074 · Arthrex, Inc. · Sep 2021
Lateralized and Augmented Baseplates
K210790 · Fx Shoulder USA, Inc. · Aug 2021