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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 / November 2025 / K252846

510(k) cleared

TaperSet Hip System

Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · Nov 20, 2025 · K252846

FDA cleared the TaperSet Hip System from Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics on Nov 20, 2025 under K252846, a special 510(k). The device falls under product code LPH, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, regulated at 21 CFR 888.3358 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 8, 2025. The decision came 73 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: K260796 (Tahoe Unicondylar Knee System with TiNbN Overcoat).

Questions & Answers

What did FDA clear under K252846?

K252846 is the FDA 510(k) for TaperSet Hip System, submitted by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. FDA's decision date was Nov 20, 2025, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the TaperSet Hip System?

Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics, based in El Dorado Hills, CA, is the applicant of record for K252846.

How long did the K252846 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Nov 20, 2025, 73 days later.

← All decisions in November 2025

Sources