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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / September 2026 / K262257

510(k) cleared

Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine

Brainlab SE · Sep 30, 2026 · K262257

FDA cleared the Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine from Brainlab SE on Sep 30, 2026 under K262257, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 2, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Brainlab SE has 2 other decisions in the tracker over the last 12 months: K261655 (RT Elements (4.6)), K254010 (ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface).

Questions & Answers

What did FDA clear under K262257?

K262257 is the FDA 510(k) for Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine, submitted by Brainlab SE. FDA's decision date was Sep 30, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine?

Brainlab SE, based in Munich, is the applicant of record for K262257.

How long did the K262257 review take?

FDA received the submission on Jul 2, 2026 and issued its decision on Sep 30, 2026, 90 days later.

← All decisions in September 2026

Sources