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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 / September 2025 / K251690

510(k) cleared

Arthrex SpeedFLEX Implant

Arthrex, Inc. · Sep 30, 2025 · K251690

FDA cleared the Arthrex SpeedFLEX Implant from Arthrex, Inc. on Sep 30, 2025 under K251690, a traditional 510(k). The device falls under product code OWY, Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 2, 2025. The decision came 120 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262357 (Arthrex Bioabsorbable PushLock Suture Anchors), K260624 (Arthrex Radial Head Replacement System), K260018 (Arthrex FiberButton), K260809 (Arthrex Sterile VAL and VAL KreuLock Compression Screw System).

Questions & Answers

What did FDA clear under K251690?

K251690 is the FDA 510(k) for Arthrex SpeedFLEX Implant, submitted by Arthrex, Inc.. FDA's decision date was Sep 30, 2025, under product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon).

Who makes the Arthrex SpeedFLEX Implant?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K251690.

How long did the K251690 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Sep 30, 2025, 120 days later.

← All decisions in September 2025