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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K254154

510(k) cleared

FX V135 EASYTECH® Shoulder System

FX Shoulder Solutions, Inc. · May 1, 2026 · K254154

FDA cleared the FX V135 EASYTECH® Shoulder System from FX Shoulder Solutions, Inc. on May 1, 2026 under K254154, a traditional 510(k). The device falls under product code PKC, Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 22, 2025. The decision came 130 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for FX Shoulder Solutions, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254154?

K254154 is the FDA 510(k) for FX V135 EASYTECH® Shoulder System, submitted by FX Shoulder Solutions, Inc.. FDA's decision date was May 1, 2026, under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained).

Who makes the FX V135 EASYTECH® Shoulder System?

FX Shoulder Solutions, Inc., based in Addison, TX, is the applicant of record for K254154.

How long did the K254154 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on May 1, 2026, 130 days later.

← All decisions in May 2026

Sources