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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 / September 2025 / K252443

510(k) cleared

SpaceFix Shoulder Spacer

G21, S.R.L. · Sep 15, 2025 · K252443

FDA cleared the SpaceFix Shoulder Spacer from G21, S.R.L. on Sep 15, 2025 under K252443, a traditional 510(k). The device falls under product code MBB, Bone Cement, Antibiotic, regulated at 21 CFR 888.3027 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 4, 2025. The decision came 42 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for G21, S.R.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252443?

K252443 is the FDA 510(k) for SpaceFix Shoulder Spacer, submitted by G21, S.R.L.. FDA's decision date was Sep 15, 2025, under product code MBB (Bone Cement, Antibiotic).

Who makes the SpaceFix Shoulder Spacer?

G21, S.R.L., based in San Possidonio, is the applicant of record for K252443.

How long did the K252443 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on Sep 15, 2025, 42 days later.

← All decisions in September 2025