ARROW Reverse Shoulder long keel and short keel glenoid base— 510(k) K142778

Name: FDA 510(k) clearance K142778
Creator: U.S. Food and Drug Administration
Published: 2015-03-20

Substantially Equivalent

Fournitures Hospitalieres Industrie

FDA 510(k) clearance K142778 for ARROW Reverse Shoulder long keel and short keel glenoid base, Substantially Equivalent on 2015-03-20. Applicant: Fournitures Hospitalieres Industrie. Device class: 2.

Clearance details

Applicant: Fournitures Hospitalieres Industrie
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2014-09-26
Decision date: 2015-03-20
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

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K171789 — ARROW Reverse Porous Glenoid2018-01-23
K163148 — BePOD® Foot Screws2017-09-14
K163710 — BePOD® EZ Weil Screws2017-09-08
K162068 — ARROW Anatomical Porous glenoid2017-04-10
K170040 — BePOD Cannulated Arthrodesis Screws2017-04-04

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.