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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 / K251771

510(k) cleared

Cambridge Partial Knee

Signature Orthopaedics Pty, Ltd. · Dec 16, 2025 · K251771

FDA cleared the Cambridge Partial Knee from Signature Orthopaedics Pty, Ltd. on Dec 16, 2025 under K251771, a traditional 510(k). The device falls under product code HSX, Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, regulated at 21 CFR 888.3520 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 10, 2025. The decision came 189 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: K252824 (Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head), K253239 (Active-V Total Knee System; World Total Knee System).

Questions & Answers

What did FDA clear under K251771?

K251771 is the FDA 510(k) for Cambridge Partial Knee, submitted by Signature Orthopaedics Pty, Ltd.. FDA's decision date was Dec 16, 2025, under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer).

Who makes the Cambridge Partial Knee?

Signature Orthopaedics Pty, Ltd., based in Lane Cove West, is the applicant of record for K251771.

How long did the K251771 review take?

FDA received the submission on Jun 10, 2025 and issued its decision on Dec 16, 2025, 189 days later.

← All decisions in December 2025

Sources