Cleared Traditional

K223211 - INHANCETM Shoulder System – Humeral Ste...

K223211 is the FDA 510(k) clearance for INHANCETM Shoulder System – Humeral Ste... by Depuy Ireland UC. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K223211 · Depuy Ireland UC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
46d
Days
Class 2
Risk

K223211 is an FDA 510(k) clearance for the INHANCETM Shoulder System – Humeral Stems and Stemless. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on December 2, 2022 after a review of 46 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy Ireland UC devices

Submission Details

510(k) Number K223211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2022
Decision Date December 02, 2022
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
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

Ignite Orthopedics, LLC
Russ Parrott

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 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K223211.
Catalyst R1 Reverse Shoulder System
K223655 · Catalyst Orthoscience, Inc. · May 2023
Arthrex Univers Revers Monoblock Stem Size 4/33
K230366 · Arthrex, Inc. · Apr 2023
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
K214001 · Biomet Manufacturing Corp · Mar 2023
Glenoid Reconstruction System
K213459 · Medacta International S.A. · Nov 2022
Humeris® 135 Shoulder System
K222936 · Fx Shoulder USA, Inc. · Nov 2022
Tornier Perform Humeral System – Fracture
K220914 · Tornier, Inc. · Oct 2022