Cleared Traditional

JARVIS Glenoid Reverse Shoulder Prosthesis

K242253 · FH Industrie · Orthopedic

Nov 2024

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K242253 is an FDA 510(k) clearance for the JARVIS Glenoid Reverse Shoulder Prosthesis, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by FH Industrie (Quimper, FR). The FDA issued a Cleared decision on November 25, 2024, 117 days after receiving the submission on July 31, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K242253 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2024
Decision Date	November 25, 2024
Days to Decision	117 days
Submission Type	Traditional
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.