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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 / March 2026 / K254233

510(k) cleared

MEDPOR Customized Implant Kit

Stryker Leibinger GmbH & Co KG · Mar 12, 2026 · K254233

FDA cleared the MEDPOR Customized Implant Kit from Stryker Leibinger GmbH & Co KG on Mar 12, 2026 under K254233, a special 510(k). The device falls under product code FWP, Prosthesis, Chin, Internal, regulated at 21 CFR 878.3550 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 29, 2025. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

Stryker Leibinger GmbH & Co KG has 3 other decisions in the tracker over the last 12 months: K261054 (RibPlate System), K253623 (Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor), K252871 (Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories).

Questions & Answers

What did FDA clear under K254233?

K254233 is the FDA 510(k) for MEDPOR Customized Implant Kit, submitted by Stryker Leibinger GmbH & Co KG. FDA's decision date was Mar 12, 2026, under product code FWP (Prosthesis, Chin, Internal).

Who makes the MEDPOR Customized Implant Kit?

Stryker Leibinger GmbH & Co KG, based in Frieburg, is the applicant of record for K254233.

How long did the K254233 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Mar 12, 2026, 73 days later.

← All decisions in March 2026