510(k) K254003

JARVIS Metaphyseal Stem by FH Industrie — Product Code PHX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 9, 2026
Date Received: December 15, 2025
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Shoulder Prosthesis, Reverse Configuration
Device Class: Class II
Regulation Number: 888.3660
Review Panel: OR
Submission Type

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.

Other clearances by FH Industrie

K253345 — JARVIS Diaphyseal Stem Standard (October 29, 2025)
K252411 — JARVIS Glenoid Reverse Shoulder Prosthesis (August 28, 2025)
K242253 — JARVIS Glenoid Reverse Shoulder Prosthesis (November 25, 2024)
K232226 — ARROW Off-Centred Humeral Insert (August 29, 2023)
K220758 — e-Ortho Shoulder Software v1.1 (September 30, 2022)
K202024 — ARROW Short Stem Humeral System (November 30, 2021)
K200127 — TELEGRAPH® EVOLUTION Humeral Nailing System (October 1, 2020)
K201928 — e-Ortho Shoulder Software (September 30, 2020)

Other clearances for product code PHX

K253624 — INHANCE Reverse Shoulder System (March 11, 2026)
K250644 — MSS - Monobloc stem (February 3, 2026)
K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (January 22, 2026)
K252567 — AltiVate Reverse® ADLC Glenosphere (January 15, 2026)
K252516 — N22 EZ Glenosphere (January 15, 2026)
K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono) (January 8, 2026)
K250338 — MSS - Humeral reverse liners extension (October 31, 2025)
K253345 — JARVIS Diaphyseal Stem Standard (October 29, 2025)
K252221 — Inset Reverse Total Shoulder System (September 26, 2025)
K252411 — JARVIS Glenoid Reverse Shoulder Prosthesis (August 28, 2025)