Cleared Special

K183696 - Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid

K183696 is an FDA 510(k) clearance for Aequalis PerFORM Reversed Glenoid, manufactured by Tornier, Inc.. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 30-day FDA review.

K183696 · Tornier, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
30d
Days
Class 2
Risk

K183696 is an FDA 510(k) clearance for the Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid. 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 30, 2019 after a review of 30 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.

FDA 510(k) Submission Details - K183696

510(k) Number K183696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2018
Decision Date January 30, 2019
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K183696.
Delta Xtend Revers Shoulder System
K192448 · Depuy(Ireland) · Oct 2019
Exactech Equinoxe Humeral Augmented Trays
K191561 · Exactech, Inc. · Aug 2019
Delta Xtend Reverse Shoulder System
K183077 · Depuy(Ireland) · May 2019
Glenoid Polyaxial Non-locking Screws
K181826 · Medacta International S.A. · Dec 2018
Integra TITAN Reverse Shoulder System
K181999 · Integra LifeSciences Corporation · Oct 2018
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
K182536 · Exactech, Inc. · Oct 2018
K183696 · Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
Download PDF FDA Summary Tornier, Inc.