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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 / K253577

510(k) cleared

IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)

Medicrea International S.A.S. (Medtronic) · Dec 19, 2025 · K253577

FDA cleared the IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) from Medicrea International S.A.S. (Medtronic) on Dec 19, 2025 under K253577, a special 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 17, 2025. The decision came 32 days later, inside the 90 FDA-day goal for a 510(k).

Medicrea International S.A.S. (Medtronic) has one other decision in the tracker over the last 12 months: K261289 (UNiD Spine Analyzer (SW3002)).

Questions & Answers

What did FDA clear under K253577?

K253577 is the FDA 510(k) for IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter), submitted by Medicrea International S.A.S. (Medtronic). FDA's decision date was Dec 19, 2025, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)?

Medicrea International S.A.S. (Medtronic), based in Rillieux-La-Pape, is the applicant of record for K253577.

How long did the K253577 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Dec 19, 2025, 32 days later.

← All decisions in December 2025

Sources