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510(k) K201391

Easytech® Anatomical Shoulder System by Fx Shoulder USA, Inc. — Product Code PKC

K201391 is an FDA 510(k) premarket notification submitted by Fx Shoulder USA, Inc. for the device "Easytech® Anatomical Shoulder System". The FDA issued a decision of Substantially Equivalent on February 16, 2021. The device falls under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained), a Class II device regulated under 21 CFR 888.3660. Fx Shoulder USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2021
Date Received
May 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Replacement of the humeral head for total anatomic shoulder arthroplasty

Other clearances by Fx Shoulder USA, Inc.

  • K240278 — Full Wedge Lateralized and Augmented Baseplates (May 15, 2024)
  • K223801 — FX V135(TM) Shoulder Prosthesis (June 5, 2023)
  • K222936 — Humeris® 135 Shoulder System (November 7, 2022)
  • K213117 — FX V135 Shoulder Prosthesis (June 7, 2022)
  • K210790 — Lateralized and Augmented Baseplates (August 25, 2021)
  • K191698 — TiN Coated Humeral Head (July 16, 2020)
  • K191146 — Humelock TiN Coated Glenosphere (July 15, 2020)
  • K193394 — Humeral Cup Stability & Humeral Cup 135/145o Stability (April 29, 2020)
  • K192799 — Glenoid Baseplate with Screw (February 21, 2020)
  • K192206 — 32mm Glenosphere and Humeral Cup (October 8, 2019)

Other clearances for product code PKC

  • K254154 — FX V135 EASYTECH® Shoulder System (May 1, 2026)
  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K243248 — INHANCE INTACT™ (December 23, 2024)
  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K221758 — SMR Stemless Anatomic (March 17, 2023)
  • K220418 — Tornier Perform Humeral System – Stemless (September 14, 2022)
  • K213615 — Shoulder Innovations Total Shoulder System (March 11, 2022)
  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K203108 — Ignite Stemless Anatomic Shoulder System (July 16, 2021)

FDA data resources