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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 / K260137

510(k) cleared

KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions

KLS-Martin L.P. · Aug 17, 2026 · K260137

FDA cleared the KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions from KLS-Martin L.P. on Aug 17, 2026 under K260137, a traditional 510(k). The device falls under product code JEY, Plate, Bone, regulated at 21 CFR 872.4760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jan 16, 2026. The decision came 213 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

KLS-Martin L.P. has 5 other decisions in the tracker over the last 12 months: K253660 (KLS Martin Pure Pectus System), K254162 (KLS Martin Ixos System), K250988 (KLS Martin Pure Pectus System), K250865 (KLS Martin IPS Forearm System).

Questions & Answers

What did FDA clear under K260137?

K260137 is the FDA 510(k) for KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions, submitted by KLS-Martin L.P.. FDA's decision date was Aug 17, 2026, under product code JEY (Plate, Bone).

Who makes the KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions?

KLS-Martin L.P., based in Jacksonville, FL, is the applicant of record for K260137.

How long did the K260137 review take?

FDA received the submission on Jan 16, 2026 and issued its decision on Aug 17, 2026, 213 days later.

← All decisions in August 2026