WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / May 2026 / K253931

510(k) cleared

Arthrex Bioabsorbable PushLock Suture Anchors

Arthrex, Inc. · May 28, 2026 · K253931

FDA cleared the Arthrex Bioabsorbable PushLock Suture Anchors from Arthrex, Inc. on May 28, 2026 under K253931, a traditional 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 Dec 9, 2025. The decision came 170 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 K253931?

K253931 is the FDA 510(k) for Arthrex Bioabsorbable PushLock Suture Anchors, submitted by Arthrex, Inc.. FDA's decision date was May 28, 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 K253931.

How long did the K253931 review take?

FDA received the submission on Dec 9, 2025 and issued its decision on May 28, 2026, 170 days later.

← All decisions in May 2026