Cleared Special

JARVIS Diaphyseal Stem Standard

K253345 · FH Industrie · Orthopedic

Oct 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K253345 is an FDA 510(k) clearance for the JARVIS Diaphyseal Stem Standard, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by FH Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on October 29, 2025, 29 days after receiving the submission on September 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K253345 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	October 29, 2025
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PHX — Shoulder Prosthesis, Reverse Configuration
Device Class	Class II — 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.