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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 / K261882

510(k) cleared

Pisces-SC Standalone Cervical Interbody System

Osseus Fusions Systems, LLC · Aug 21, 2026 · K261882

FDA cleared the Pisces-SC Standalone Cervical Interbody System from Osseus Fusions Systems, LLC on Aug 21, 2026 under K261882, a traditional 510(k). The device falls under product code OVE, Intervertebral Fusion Device With Integrated Fixation, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 5, 2026. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Osseus Fusions Systems, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261882?

K261882 is the FDA 510(k) for Pisces-SC Standalone Cervical Interbody System, submitted by Osseus Fusions Systems, LLC. FDA's decision date was Aug 21, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the Pisces-SC Standalone Cervical Interbody System?

Osseus Fusions Systems, LLC, based in Dallas, TX, is the applicant of record for K261882.

How long did the K261882 review take?

FDA received the submission on Jun 5, 2026 and issued its decision on Aug 21, 2026, 77 days later.

← All decisions in August 2026