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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K262290

510(k) cleared

REMEDY POLY+PLUS SNAP FIT Acetabular Cup

Osteoremedies, LLC · Jul 24, 2026 · K262290

FDA cleared the REMEDY POLY+PLUS SNAP FIT Acetabular Cup from Osteoremedies, LLC on Jul 24, 2026 under K262290, a special 510(k). The device falls under product code KWL, Prosthesis, Hip, Hemi-, Femoral, Metal, regulated at 21 CFR 888.3360 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 6, 2026. The decision came 18 days later, inside the 90 FDA-day goal for a 510(k).

Osteoremedies, LLC has one other decision in the tracker over the last 12 months: K253675 (OsteoRemedies Hip Spacer System).

Questions & Answers

What did FDA clear under K262290?

K262290 is the FDA 510(k) for REMEDY POLY+PLUS SNAP FIT Acetabular Cup, submitted by Osteoremedies, LLC. FDA's decision date was Jul 24, 2026, under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal).

Who makes the REMEDY POLY+PLUS SNAP FIT Acetabular Cup?

Osteoremedies, LLC, based in Germantown, TN, is the applicant of record for K262290.

How long did the K262290 review take?

FDA received the submission on Jul 6, 2026 and issued its decision on Jul 24, 2026, 18 days later.

← All decisions in July 2026

Sources