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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 / September 2025 / K252221

510(k) cleared

Inset Reverse Total Shoulder System

Shoulder Innovations, Inc. · Sep 26, 2025 · K252221

FDA cleared the Inset Reverse Total Shoulder System from Shoulder Innovations, Inc. on Sep 26, 2025 under K252221, 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 Jul 16, 2025. The decision came 72 days later, inside the 90 FDA-day goal for a 510(k).

Shoulder Innovations, Inc. has 2 other decisions in the tracker over the last 12 months: K254128 (InSet Reverse Total Shoulder System), K252516 (N22 EZ Glenosphere).

Questions & Answers

What did FDA clear under K252221?

K252221 is the FDA 510(k) for Inset Reverse Total Shoulder System, submitted by Shoulder Innovations, Inc.. FDA's decision date was Sep 26, 2025, 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 K252221.

How long did the K252221 review take?

FDA received the submission on Jul 16, 2025 and issued its decision on Sep 26, 2025, 72 days later.

← All decisions in September 2025

Sources