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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 / April 2026 / K261032

510(k) cleared

NovoKnee (SteriKnee)

NovoSource · Apr 27, 2026 · K261032

FDA cleared the NovoKnee (SteriKnee) from NovoSource on Apr 27, 2026 under K261032, a special 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 30, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for NovoSource in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261032?

K261032 is the FDA 510(k) for NovoKnee (SteriKnee), submitted by NovoSource. FDA's decision date was Apr 27, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the NovoKnee (SteriKnee)?

NovoSource, based in Morgantown, WV, is the applicant of record for K261032.

How long did the K261032 review take?

FDA received the submission on Mar 30, 2026 and issued its decision on Apr 27, 2026, 28 days later.

← All decisions in April 2026