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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 / K260583

510(k) cleared

Equinoxe® Shoulder System

Exactech, Inc. · Apr 14, 2026 · K260583

FDA cleared the Equinoxe® Shoulder System from Exactech, Inc. on Apr 14, 2026 under K260583, 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 Feb 20, 2026. The decision came 53 days later, inside the 90 FDA-day goal for a 510(k).

Exactech, Inc. has one other decision in the tracker over the last 12 months: K250713 (Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants).

Questions & Answers

What did FDA clear under K260583?

K260583 is the FDA 510(k) for Equinoxe® Shoulder System, submitted by Exactech, Inc.. FDA's decision date was Apr 14, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the Equinoxe® Shoulder System?

Exactech, Inc., based in Gainesville, FL, is the applicant of record for K260583.

How long did the K260583 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on Apr 14, 2026, 53 days later.

← All decisions in April 2026

Sources