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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 / March 2026 / K253624

510(k) cleared

INHANCE Reverse Shoulder System

Depuy Ireland UC · Mar 11, 2026 · K253624

FDA cleared the INHANCE Reverse Shoulder System from Depuy Ireland UC on Mar 11, 2026 under K253624, 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 Nov 18, 2025. The decision came 113 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Depuy Ireland UC has 5 other decisions in the tracker over the last 12 months: K260480 (VELYS Robotic-Assisted Solution), K261458 (ATTUNE Total Knee System; ATTUNE Cementless Knee System), K260536 (Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement), K253551 (VELYS Hip Navigation).

Questions & Answers

What did FDA clear under K253624?

K253624 is the FDA 510(k) for INHANCE Reverse Shoulder System, submitted by Depuy Ireland UC. FDA's decision date was Mar 11, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the INHANCE Reverse Shoulder System?

Depuy Ireland UC, based in Cork, is the applicant of record for K253624.

How long did the K253624 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Mar 11, 2026, 113 days later.

← All decisions in March 2026