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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 / August 2026 / K262357

510(k) cleared

Arthrex Bioabsorbable PushLock Suture Anchors

Arthrex, Inc. · Aug 7, 2026 · K262357

FDA cleared the Arthrex Bioabsorbable PushLock Suture Anchors from Arthrex, Inc. on Aug 7, 2026 under K262357, a special 510(k). The device falls under product code MAI, Fastener, Fixation, Biodegradable, Soft Tissue, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 10, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K260624 (Arthrex Radial Head Replacement System), K260018 (Arthrex FiberButton), K260809 (Arthrex Sterile VAL and VAL KreuLock Compression Screw System), K253931 (Arthrex Bioabsorbable PushLock Suture Anchors).

Questions & Answers

What did FDA clear under K262357?

K262357 is the FDA 510(k) for Arthrex Bioabsorbable PushLock Suture Anchors, submitted by Arthrex, Inc.. FDA's decision date was Aug 7, 2026, under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue).

Who makes the Arthrex Bioabsorbable PushLock Suture Anchors?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K262357.

How long did the K262357 review take?

FDA received the submission on Jul 10, 2026 and issued its decision on Aug 7, 2026, 28 days later.

← All decisions in August 2026