Cleared Traditional

K212737 - INHANCE Reverse Shoulder System

K212737 is the FDA 510(k) clearance for INHANCE Reverse Shoulder System by Depuy Ireland UC. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K212737 · Depuy Ireland UC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
234d
Days
Class 2
Risk

K212737 is an FDA 510(k) clearance for the INHANCE™ Reverse Shoulder System. 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 April 21, 2022 after a review of 234 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 Depuy Ireland UC devices

Submission Details

510(k) Number K212737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2021
Decision Date April 21, 2022
Days to Decision 234 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
112d slower than avg
Panel avg: 122d · This submission: 234d
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 K212737.
INHANCETM Reverse Glenoid Peripheral Posts
K221467 · Depuy Ireland UC · Aug 2022
Catalyst R1 Reverse Shoulder System
K213349 · Catalyst Orthoscience, Inc. · Jun 2022
FX V135 Shoulder Prosthesis
K213117 · Fx Shoulder USA, Inc. · Jun 2022
PRIMA Humeral System and SMR Glenosphere Ø42
K212800 · Lima Corporate S.P.A. · Feb 2022
ARROW Short Stem Humeral System
K202024 · FH Industrie · Nov 2021
LINK® Embrace Shoulder System - Reverse Configuration
K212992 · Waldemar Link GmbH & Co. KG · Nov 2021