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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K261381

510(k) cleared

TiLink-L SI Joint Fusion System

SurGenTec, LLC · Aug 24, 2026 · K261381

FDA cleared the TiLink-L SI Joint Fusion System from SurGenTec, LLC on Aug 24, 2026 under K261381, 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 Apr 27, 2026. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SurGenTec, LLC has 6 other decisions in the tracker over the last 12 months: K262581 (GraftGun Universal Graft Delivery System (GDS®)), K262121 (Ion-L Navigated Instruments), K261209 (Ion-L), K260329 (Ion-C Navigation Instruments).

Questions & Answers

What did FDA clear under K261381?

K261381 is the FDA 510(k) for TiLink-L SI Joint Fusion System, submitted by SurGenTec, LLC. FDA's decision date was Aug 24, 2026, under product code OUR (Sacroiliac Joint Fixation).

Who makes the TiLink-L SI Joint Fusion System?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K261381.

How long did the K261381 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Aug 24, 2026, 119 days later.

← All decisions in August 2026

Sources