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 / February 2026 / K253488

510(k) cleared

iFuse INTRA Ti Implant System

SI-BONE, Inc. · Feb 11, 2026 · K253488

FDA cleared the iFuse INTRA Ti Implant System from SI-BONE, Inc. on Feb 11, 2026 under K253488, a traditional 510(k). The device falls under product code OUR, Sacroiliac Joint Fixation, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Oct 24, 2025. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SI-BONE, Inc. has 2 other decisions in the tracker over the last 12 months: K253094 (iFuse Bedrock Granite Implant System), K251780 (iGPS Navigation Instruments).

Questions & Answers

What did FDA clear under K253488?

K253488 is the FDA 510(k) for iFuse INTRA Ti Implant System, submitted by SI-BONE, Inc.. FDA's decision date was Feb 11, 2026, under product code OUR (Sacroiliac Joint Fixation).

Who makes the iFuse INTRA Ti Implant System?

SI-BONE, Inc., based in Santa Clara, CA, is the applicant of record for K253488.

How long did the K253488 review take?

FDA received the submission on Oct 24, 2025 and issued its decision on Feb 11, 2026, 110 days later.

← All decisions in February 2026

Sources