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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 / K253515

510(k) cleared

Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments

Biomet Orthopedics, Inc. · Aug 24, 2026 · K253515

FDA cleared the Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments from Biomet Orthopedics, Inc. on Aug 24, 2026 under K253515, a traditional 510(k). The device falls under product code JDI, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, regulated at 21 CFR 888.3350 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 7, 2025. The decision came 290 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Biomet Orthopedics, Inc. has one other decision in the tracker over the last 12 months: K252404 (Comprehensive Reverse Shoulder - HA Glenosphere Baseplates).

Questions & Answers

What did FDA clear under K253515?

K253515 is the FDA 510(k) for Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments, submitted by Biomet Orthopedics, Inc.. FDA's decision date was Aug 24, 2026, under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented).

Who makes the Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments?

Biomet Orthopedics, Inc., based in Warsaw, IN, is the applicant of record for K253515.

How long did the K253515 review take?

FDA received the submission on Nov 7, 2025 and issued its decision on Aug 24, 2026, 290 days later.

← All decisions in August 2026

Sources