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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 / January 2026 / K252567

510(k) cleared

AltiVate Reverse® ADLC Glenosphere

Encore Medical L.P. · Jan 15, 2026 · K252567

FDA cleared the AltiVate Reverse® ADLC Glenosphere from Encore Medical L.P. on Jan 15, 2026 under K252567, 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 Aug 14, 2025. The decision came 154 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Encore Medical L.P. has 2 other decisions in the tracker over the last 12 months: K252974 (EMPOWR Knee), K251833 (EMPOWR Acetabular® Liner Extension).

Questions & Answers

What did FDA clear under K252567?

K252567 is the FDA 510(k) for AltiVate Reverse® ADLC Glenosphere, submitted by Encore Medical L.P.. FDA's decision date was Jan 15, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the AltiVate Reverse® ADLC Glenosphere?

Encore Medical L.P., based in Austin, TX, is the applicant of record for K252567.

How long did the K252567 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Jan 15, 2026, 154 days later.

← All decisions in January 2026

Sources