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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 / April 2026 / K254128

510(k) cleared

InSet Reverse Total Shoulder System

Shoulder Innovations, Inc. · Apr 13, 2026 · K254128

FDA cleared the InSet Reverse Total Shoulder System from Shoulder Innovations, Inc. on Apr 13, 2026 under K254128, a traditional 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, 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 112 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shoulder Innovations, Inc. has 2 other decisions in the tracker over the last 12 months: K252516 (N22 EZ Glenosphere), K252221 (Inset Reverse Total Shoulder System).

Questions & Answers

What did FDA clear under K254128?

K254128 is the FDA 510(k) for InSet Reverse Total Shoulder System, submitted by Shoulder Innovations, Inc.. FDA's decision date was Apr 13, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the InSet Reverse Total Shoulder System?

Shoulder Innovations, Inc., based in Grand Rapids, MI, is the applicant of record for K254128.

How long did the K254128 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Apr 13, 2026, 112 days later.

← All decisions in April 2026

Sources