Easytech® Anatomical Shoulder System— 510(k) K201391

Name: FDA 510(k) clearance K201391
Creator: U.S. Food and Drug Administration
Published: 2021-02-16

Substantially Equivalent

Fx Shoulder USA, Inc.

FDA 510(k) clearance K201391 for Easytech® Anatomical Shoulder System, Substantially Equivalent on 2021-02-16. Applicant: Fx Shoulder USA, Inc.. Device class: 2.

Clearance details

Applicant: Fx Shoulder USA, Inc.
Product code: Code PKC
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2020-05-27
Decision date: 2021-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKC

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K254154 — FX V135 EASYTECH® Shoulder System2026-05-01
K252129 — AETOS Shoulder System Stemless Humeral Prosthesis2025-10-03
K243248 — INHANCE INTACT2024-12-23
K241873 — OsseoFit Stemless Shoulder System2024-12-11
K240716 — AETOS Shoulder System Stemless Humeral Prosthesis2024-11-20

More clearances from Fx Shoulder USA, Inc.

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K240278 — Full Wedge Lateralized and Augmented Baseplates2024-05-15
K223801 — FX V135(TM) Shoulder Prosthesis2023-06-05
K222936 — Humeris® 135 Shoulder System2022-11-07
K213117 — FX V135 Shoulder Prosthesis2022-06-07
K210790 — Lateralized and Augmented Baseplates2021-08-25

Adverse events under product code PKC

product code PKC

Injury: 258
Total: 258

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.