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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 / K261054

510(k) cleared

RibPlate System

Stryker Leibinger GmbH & Co KG · Jul 1, 2026 · K261054

FDA cleared the RibPlate System from Stryker Leibinger GmbH & Co KG on Jul 1, 2026 under K261054, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 31, 2026. The decision came 92 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Leibinger GmbH & Co KG has 3 other decisions in the tracker over the last 12 months: K254233 (MEDPOR Customized Implant Kit), 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 K261054?

K261054 is the FDA 510(k) for RibPlate System, submitted by Stryker Leibinger GmbH & Co KG. FDA's decision date was Jul 1, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the RibPlate System?

Stryker Leibinger GmbH & Co KG, based in Freiburg, is the applicant of record for K261054.

How long did the K261054 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Jul 1, 2026, 92 days later.

← All decisions in July 2026