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510(k) K254154

FX V135 EASYTECH® Shoulder System by FX Shoulder Solutions, Inc. — Product Code PKC

K254154 is an FDA 510(k) premarket notification submitted by FX Shoulder Solutions, Inc. for the device "FX V135 EASYTECH® Shoulder System". The FDA issued a decision of Substantially Equivalent on May 1, 2026. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2026
Date Received
December 22, 2025
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 for product code PKC

  • 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)
  • K201391 — Easytech® Anatomical Shoulder System (February 16, 2021)

FDA data resources