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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 / K253239

510(k) cleared

Active-V Total Knee System; World Total Knee System

Signature Orthopaedics Pty, Ltd. · Dec 23, 2025 · K253239

FDA cleared the Active-V Total Knee System; World Total Knee System from Signature Orthopaedics Pty, Ltd. on Dec 23, 2025 under K253239, a traditional 510(k). The device falls under product code MBH, Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, regulated at 21 CFR 888.3565 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 29, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Signature Orthopaedics Pty, Ltd. has 2 other decisions in the tracker over the last 12 months: K252824 (Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head), K251771 (Cambridge Partial Knee).

Questions & Answers

What did FDA clear under K253239?

K253239 is the FDA 510(k) for Active-V Total Knee System; World Total Knee System, submitted by Signature Orthopaedics Pty, Ltd.. FDA's decision date was Dec 23, 2025, under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer).

Who makes the Active-V Total Knee System; World Total Knee System?

Signature Orthopaedics Pty, Ltd., based in Lane Cove West, is the applicant of record for K253239.

How long did the K253239 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Dec 23, 2025, 85 days later.

← All decisions in December 2025

Sources