Cleared Traditional

K181826 - Glenoid Polyaxial Non-locking Screws

K181826 is the FDA 510(k) clearance for Glenoid Polyaxial Non-locking Screws by Medacta International S.A.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K181826 · Medacta International S.A. · Orthopedic device
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Dec 2018
Decision
154d
Days
Class 2
Risk

K181826 is an FDA 510(k) clearance for the Glenoid Polyaxial Non-locking Screws. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on December 10, 2018 after a review of 154 days - an extended review cycle.

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 Medacta International S.A. devices

Submission Details

510(k) Number K181826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date December 10, 2018
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
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 Consultant

Medacta USA
Chris Lussier

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PHX Shoulder Prosthesis, Reverse Configuration

All 180
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K181826.
Exactech Equinoxe Humeral Augmented Trays
K191561 · Exactech, Inc. · Aug 2019
Delta Xtend Reverse Shoulder System
K183077 · Depuy(Ireland) · May 2019
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
K183696 · Tornier, Inc. · Jan 2019
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
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
K182039 · Arthrex, Inc. · Sep 2018