Cleared Special

K252411 - JARVIS Glenoid Reverse Shoulder Prosthesis

K252411 is an FDA 510(k) clearance for JARVIS Glenoid Reverse Shoulder Prosthesis, manufactured by FH Industrie. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 27-day FDA review.

K252411 · FH Industrie · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
27d
Days
Class 2
Risk

K252411 is an FDA 510(k) clearance for the JARVIS Glenoid Reverse Shoulder Prosthesis. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by FH Industrie (Quimper, FR). The FDA issued a Cleared decision on August 28, 2025 after a review of 27 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.

View all FH Industrie devices

FDA 510(k) Submission Details - K252411

510(k) Number K252411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2025
Decision Date August 28, 2025
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 Consultant

MRC Global
Christine Scifert

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 183
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K252411.
MSS - Humeral reverse liners extension
K250338 · Medacta International S.A. · Oct 2025
JARVIS Diaphyseal Stem Standard
K253345 · FH Industrie · Oct 2025
Inset Reverse Total Shoulder System
K252221 · Shoulder Innovations, Inc. · Sep 2025
AltiVate Reverse® Glenoid
K252141 · Encore Medical, L.P. · Aug 2025
Equinoxe® Shoulder System
K243448 · Exactech, Inc. · Aug 2025
SMR Reverse HP Shoulder System
K243826 · Lima Corporate S.P.A. · Jul 2025