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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 / July 2026 / K261770

510(k) cleared

Suture Button Repair System

Skeletal Dynamics, Inc. · Jul 29, 2026 · K261770

FDA cleared the Suture Button Repair System from Skeletal Dynamics, Inc. on Jul 29, 2026 under K261770, a traditional 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 May 29, 2026. The decision came 61 days later, inside the 90 FDA-day goal for a 510(k).

Skeletal Dynamics, Inc. has 2 other decisions in the tracker over the last 12 months: K254288 (Clavicle Fixation System), K252949 (Geminus Volar Distal Radius Plating System).

Questions & Answers

What did FDA clear under K261770?

K261770 is the FDA 510(k) for Suture Button Repair System, submitted by Skeletal Dynamics, Inc.. FDA's decision date was Jul 29, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Suture Button Repair System?

Skeletal Dynamics, Inc., based in Miami, FL, is the applicant of record for K261770.

How long did the K261770 review take?

FDA received the submission on May 29, 2026 and issued its decision on Jul 29, 2026, 61 days later.

← All decisions in July 2026

Sources