JARVIS Glenoid Reverse Shoulder Prosthesis— 510(k) K242253

Name: FDA 510(k) clearance K242253
Creator: U.S. Food and Drug Administration
Published: 2024-11-25

Substantially Equivalent

FH Industrie

FDA 510(k) clearance K242253 for JARVIS Glenoid Reverse Shoulder Prosthesis, Substantially Equivalent on 2024-11-25. Applicant: FH Industrie. Device class: 2.

Clearance details

Applicant: FH Industrie
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2024-07-31
Decision date: 2024-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quimper, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

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K260556 — Veritas Shoulder System2026-07-01
K261683 — Augment Off-Axis Instrument System2026-06-16
K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System2026-06-12
K261016 — MSS - Humeral reverse liners extension2026-06-10
K253992 — Veritas Reverse Total Shoulder System2026-05-07

More clearances from FH Industrie

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K254003 — JARVIS Metaphyseal Stem2026-01-09
K253345 — JARVIS Diaphyseal Stem Standard2025-10-29
K252411 — JARVIS Glenoid Reverse Shoulder Prosthesis2025-08-28
K232226 — ARROW Off-Centred Humeral Insert2023-08-29
K220758 — e-Ortho Shoulder Software v1.12022-09-30

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.