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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 / K260106

510(k) cleared

OsteoCoil GT Active Compression System

Flower Orthopedics Corporation DBA Conventus Flower Orthoped · Aug 24, 2026 · K260106

FDA cleared the OsteoCoil GT Active Compression System from Flower Orthopedics Corporation DBA Conventus Flower Orthoped on Aug 24, 2026 under K260106, a traditional 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 14, 2026. The decision came 222 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Flower Orthopedics Corporation DBA Conventus Flower Orthoped in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260106?

K260106 is the FDA 510(k) for OsteoCoil GT Active Compression System, submitted by Flower Orthopedics Corporation DBA Conventus Flower Orthoped. FDA's decision date was Aug 24, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the OsteoCoil GT Active Compression System?

Flower Orthopedics Corporation DBA Conventus Flower Orthoped, based in Horsham, PA, is the applicant of record for K260106.

How long did the K260106 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Aug 24, 2026, 222 days later.

← All decisions in August 2026