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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 / December 2025 / K253675

510(k) cleared

OsteoRemedies Hip Spacer System

Osteoremedies, LLC · Dec 23, 2025 · K253675

FDA cleared the OsteoRemedies Hip Spacer System from Osteoremedies, LLC on Dec 23, 2025 under K253675, 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 Nov 21, 2025. The decision came 32 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: K262290 (REMEDY POLY+PLUS SNAP FIT Acetabular Cup).

Questions & Answers

What did FDA clear under K253675?

K253675 is the FDA 510(k) for OsteoRemedies Hip Spacer System, submitted by Osteoremedies, LLC. FDA's decision date was Dec 23, 2025, under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal).

Who makes the OsteoRemedies Hip Spacer System?

Osteoremedies, LLC, based in Germantown, TN, is the applicant of record for K253675.

How long did the K253675 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Dec 23, 2025, 32 days later.

← All decisions in December 2025

Sources