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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 / K260796

510(k) cleared

Tahoe Unicondylar Knee System with TiNbN Overcoat

Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · Apr 2, 2026 · K260796

FDA cleared the Tahoe Unicondylar Knee System with TiNbN Overcoat from Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics on Apr 2, 2026 under K260796, a special 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 Mar 11, 2026. The decision came 22 days later, inside the 90 FDA-day goal for a 510(k).

Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics has one other decision in the tracker over the last 12 months: K252846 (TaperSet Hip System).

Questions & Answers

What did FDA clear under K260796?

K260796 is the FDA 510(k) for Tahoe Unicondylar Knee System with TiNbN Overcoat, submitted by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. FDA's decision date was Apr 2, 2026, under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer).

Who makes the Tahoe Unicondylar Knee System with TiNbN Overcoat?

Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics, based in El Dorado Hills, CA, is the applicant of record for K260796.

How long did the K260796 review take?

FDA received the submission on Mar 11, 2026 and issued its decision on Apr 2, 2026, 22 days later.

← All decisions in April 2026

Sources