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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 / December 2025 / K250713

510(k) cleared

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

Exactech, Inc. · Dec 1, 2025 · K250713

FDA cleared the Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants from Exactech, Inc. on Dec 1, 2025 under K250713, a traditional 510(k). The device falls under product code KWT, Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, regulated at 21 CFR 888.3650 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 10, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Exactech, Inc. has one other decision in the tracker over the last 12 months: K260583 (Equinoxe® Shoulder System).

Questions & Answers

What did FDA clear under K250713?

K250713 is the FDA 510(k) for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants, submitted by Exactech, Inc.. FDA's decision date was Dec 1, 2025, under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented).

Who makes the Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

Exactech, Inc., based in Gainesville, FL, is the applicant of record for K250713.

How long did the K250713 review take?

FDA received the submission on Mar 10, 2025 and issued its decision on Dec 1, 2025, 266 days later.

← All decisions in December 2025

Sources