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FDA 510(k)

FX V135 EASYTECH® Shoulder System

K-Number: K254154 · 2026-05-01

ApplicantFX Shoulder Solutions, Inc.
Decision Date2026-05-01
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FX V135 EASYTECH® Shoulder System is a medical device manufactured by FX Shoulder Solutions, Inc.. It received FDA 510(k) clearance on 2026-05-01 under approval number K254154. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FX V135 EASYTECH® Shoulder System?

FX V135 EASYTECH® Shoulder System is a medical device that received FDA 510(k) clearance on 2026-05-01. It is manufactured by FX Shoulder Solutions, Inc.. The 510(k) number is K254154.

When was FX V135 EASYTECH® Shoulder System approved by the FDA?

FX V135 EASYTECH® Shoulder System received FDA 510(k) clearance on 2026-05-01, under approval number K254154.

What company makes FX V135 EASYTECH® Shoulder System?

FX V135 EASYTECH® Shoulder System is manufactured by FX Shoulder Solutions, Inc..

What is the FDA product code for FX V135 EASYTECH® Shoulder System?

The FDA product code for FX V135 EASYTECH® Shoulder System is PKC.

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Official Source

View on FDA Database →

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