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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K262341

510(k) cleared

b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions

B-One Ortho, Corp. · Sep 8, 2026 · K262341

FDA cleared the b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions from B-One Ortho, Corp. on Sep 8, 2026 under K262341, a traditional 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 Jul 10, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

B-One Ortho, Corp. has 2 other decisions in the tracker over the last 12 months: K261352 (2D Hip Planning Software), K253357 (b-ONE® Bipolar Head).

Questions & Answers

What did FDA clear under K262341?

K262341 is the FDA 510(k) for b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions, submitted by B-One Ortho, Corp.. FDA's decision date was Sep 8, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions?

B-One Ortho, Corp., based in Cedar Knolls, NJ, is the applicant of record for K262341.

How long did the K262341 review take?

FDA received the submission on Jul 10, 2026 and issued its decision on Sep 8, 2026, 60 days later.

← All decisions in September 2026

Sources