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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 / K252824

510(k) cleared

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

Signature Orthopaedics Pty, Ltd. · Mar 12, 2026 · K252824

FDA cleared the Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head from Signature Orthopaedics Pty, Ltd. on Mar 12, 2026 under K252824, a traditional 510(k). The device falls under product code JDI, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, regulated at 21 CFR 888.3350 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 5, 2025. The decision came 188 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Signature Orthopaedics Pty, Ltd. has 2 other decisions in the tracker over the last 12 months: K253239 (Active-V Total Knee System; World Total Knee System), K251771 (Cambridge Partial Knee).

Questions & Answers

What did FDA clear under K252824?

K252824 is the FDA 510(k) for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head, submitted by Signature Orthopaedics Pty, Ltd.. FDA's decision date was Mar 12, 2026, under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented).

Who makes the Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

Signature Orthopaedics Pty, Ltd., based in Lane Cove West, is the applicant of record for K252824.

How long did the K252824 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on Mar 12, 2026, 188 days later.

← All decisions in March 2026

Sources