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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 / June 2026 / K261481

510(k) cleared

Pangea Femur Reconstruction System

Stryker GmbH · Jun 29, 2026 · K261481

FDA cleared the Pangea Femur Reconstruction System from Stryker GmbH on Jun 29, 2026 under K261481, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 5, 2026. The decision came 55 days later, inside the 90 FDA-day goal for a 510(k).

Stryker GmbH has 2 other decisions in the tracker over the last 12 months: K253640 (T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System), K253202 (Hoffmann LRF System).

Questions & Answers

What did FDA clear under K261481?

K261481 is the FDA 510(k) for Pangea Femur Reconstruction System, submitted by Stryker GmbH. FDA's decision date was Jun 29, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Pangea Femur Reconstruction System?

Stryker GmbH, based in Selzach, is the applicant of record for K261481.

How long did the K261481 review take?

FDA received the submission on May 5, 2026 and issued its decision on Jun 29, 2026, 55 days later.

← All decisions in June 2026

Sources