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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 / February 2026 / K253695

510(k) cleared

LigaMend

Riverpoint Medical, LLC · Feb 27, 2026 · K253695

FDA cleared the LigaMend from Riverpoint Medical, LLC on Feb 27, 2026 under K253695, 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 Nov 21, 2025. The decision came 98 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Riverpoint Medical, LLC has 2 other decisions in the tracker over the last 12 months: K253693 (Strut Suture; No-Tie Button), K253024 (ProZip Knotless Implant).

Questions & Answers

What did FDA clear under K253695?

K253695 is the FDA 510(k) for LigaMend, submitted by Riverpoint Medical, LLC. FDA's decision date was Feb 27, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the LigaMend?

Riverpoint Medical, LLC, based in Portland, OR, is the applicant of record for K253695.

How long did the K253695 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Feb 27, 2026, 98 days later.

← All decisions in February 2026

Sources