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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 / February 2026 / K253640

510(k) cleared

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System

Stryker GmbH · Feb 3, 2026 · K253640

FDA cleared the T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System from Stryker GmbH on Feb 3, 2026 under K253640, 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 Nov 19, 2025. The decision came 76 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: K261481 (Pangea Femur Reconstruction System), K253202 (Hoffmann LRF System).

Questions & Answers

What did FDA clear under K253640?

K253640 is the FDA 510(k) for T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System, submitted by Stryker GmbH. FDA's decision date was Feb 3, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System?

Stryker GmbH, based in Selzach, Solothurn, Ch, is the applicant of record for K253640.

How long did the K253640 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Feb 3, 2026, 76 days later.

← All decisions in February 2026

Sources