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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 / March 2026 / K253604

510(k) cleared

TiLink-L Navigation Instruments

SurGenTec, LLC · Mar 20, 2026 · K253604

FDA cleared the TiLink-L Navigation Instruments from SurGenTec, LLC on Mar 20, 2026 under K253604, 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 Nov 18, 2025. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SurGenTec, LLC has 7 other decisions in the tracker over the last 12 months: K252995 (Durashield Device Kit), K262581 (GraftGun Universal Graft Delivery System (GDS®)), K261381 (TiLink-L SI Joint Fusion System), K262121 (Ion-L Navigated Instruments).

Questions & Answers

What did FDA clear under K253604?

K253604 is the FDA 510(k) for TiLink-L Navigation Instruments, submitted by SurGenTec, LLC. FDA's decision date was Mar 20, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the TiLink-L Navigation Instruments?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K253604.

How long did the K253604 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Mar 20, 2026, 122 days later.

← All decisions in March 2026