Cleared Special

K152966 - Aequalis Fx2

K152966 is an FDA 510(k) clearance for Aequalis Fx2, manufactured by Tornier S.A.S.. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 99-day FDA review.

K152966 · Tornier S.A.S. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
99d
Days
Class 2
Risk

K152966 is an FDA 510(k) clearance for the Aequalis Fx2. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Tornier S.A.S. (Montbonnot Saint Martin, FR). The FDA issued a Cleared decision on January 14, 2016 after a review of 99 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K152966

510(k) Number K152966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2015
Decision Date January 14, 2016
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

PHX Device Classification - Class 2, Special Controls

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 206
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K152966.
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
K161742 · Tornier, Inc. · Nov 2016
Integra TITAN Reverse Shoulder System
K161189 · Integra LifeSciences Corporation · Aug 2016
COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
K152754 · Biomet Manufacturing Corp · May 2016
Humelock II Reversible Shoulder System
K150488 · Fx Solutions · Nov 2015
ARROW Humeral stems size 6 and 16
K150568 · Fournitures Hospitalieres Industrie · Oct 2015
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
K150458 · Exactech, Inc. · May 2015
K152966 · Aequalis Fx2
Download PDF FDA Summary Tornier S.A.S.