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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 / October 2025 / K253145

510(k) cleared

Pre-Sutured Tendon

Rti Surgical, Inc. · Oct 22, 2025 · K253145

FDA cleared the Pre-Sutured Tendon from Rti Surgical, Inc. on Oct 22, 2025 under K253145, a special 510(k). The device falls under product code GAT, Suture, Nonabsorbable, Synthetic, Polyethylene, regulated at 21 CFR 878.5000 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 25, 2025. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Rti Surgical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253145?

K253145 is the FDA 510(k) for Pre-Sutured Tendon, submitted by Rti Surgical, Inc.. FDA's decision date was Oct 22, 2025, under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Who makes the Pre-Sutured Tendon?

Rti Surgical, Inc., based in Alachua, FL, is the applicant of record for K253145.

How long did the K253145 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Oct 22, 2025, 27 days later.

← All decisions in October 2025