JARVIS Diaphyseal Stem Standard— 510(k) K253345

Substantially Equivalent

FH Industrie

FDA 510(k) clearance K253345 for JARVIS Diaphyseal Stem Standard, Substantially Equivalent on 2025-10-29. Applicant: FH Industrie.

Clearance details

Applicant: FH Industrie
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2025-09-30
Decision date: 2025-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Quimper Finistere, FR

Download summary PDF View on FDA.gov ↗

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.