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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 / February 2026 / K253488

510(k) cleared

iFuse INTRA Ti Implant System

SI-BONE, Inc. · Feb 11, 2026 · K253488

FDA cleared the iFuse INTRA Ti Implant System from SI-BONE, Inc. on Feb 11, 2026 under K253488, a traditional 510(k). The device falls under product code OUR, Sacroiliac Joint Fixation, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Oct 24, 2025. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SI-BONE, Inc. has one other decision in the tracker over the last 12 months: K262067 (iFuse Granite Onyx Implant System).

Questions & Answers

What did FDA clear under K253488?

K253488 is the FDA 510(k) for iFuse INTRA Ti Implant System, submitted by SI-BONE, Inc.. FDA's decision date was Feb 11, 2026, under product code OUR (Sacroiliac Joint Fixation).

Who makes the iFuse INTRA Ti Implant System?

SI-BONE, Inc., based in Santa Clara, CA, is the applicant of record for K253488.

How long did the K253488 review take?

FDA received the submission on Oct 24, 2025 and issued its decision on Feb 11, 2026, 110 days later.

← All decisions in February 2026

Sources