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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 / K262047

510(k) cleared

Grappler Suture Anchor System

Paragon 28, Inc. · Aug 3, 2026 · K262047

FDA cleared the Grappler Suture Anchor System from Paragon 28, Inc. on Aug 3, 2026 under K262047, a special 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 18, 2026. The decision came 46 days later, inside the 90 FDA-day goal for a 510(k).

Paragon 28, Inc. has 5 other decisions in the tracker over the last 12 months: K261121 (Megalodon Dynamic Compression System), K253886 (Grappler Suture Anchor PCFD Tether System), K253591 (Phantom® Hindfoot TTC/TC Nail System), K253613 (Monkey Rings External Ring Fixation System).

Questions & Answers

What did FDA clear under K262047?

K262047 is the FDA 510(k) for Grappler Suture Anchor System, submitted by Paragon 28, Inc.. FDA's decision date was Aug 3, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Grappler Suture Anchor System?

Paragon 28, Inc., based in Englewood, CO, is the applicant of record for K262047.

How long did the K262047 review take?

FDA received the submission on Jun 18, 2026 and issued its decision on Aug 3, 2026, 46 days later.

← All decisions in August 2026