WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253357

510(k) cleared

b-ONE® Bipolar Head

B-One Ortho, Corp. · Apr 13, 2026 · K253357

FDA cleared the b-ONE® Bipolar Head from B-One Ortho, Corp. on Apr 13, 2026 under K253357, a traditional 510(k). The device falls under product code KWY, Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, regulated at 21 CFR 888.3390 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2025. The decision came 195 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

B-One Ortho, Corp. has one other decision in the tracker over the last 12 months: K261352 (2D Hip Planning Software).

Questions & Answers

What did FDA clear under K253357?

K253357 is the FDA 510(k) for b-ONE® Bipolar Head, submitted by B-One Ortho, Corp.. FDA's decision date was Apr 13, 2026, under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented).

Who makes the b-ONE® Bipolar Head?

B-One Ortho, Corp., based in Cedar Knolls, NJ, is the applicant of record for K253357.

How long did the K253357 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Apr 13, 2026, 195 days later.

← All decisions in April 2026

Sources