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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 / K253094

510(k) cleared

iFuse Bedrock Granite Implant System

SI-BONE, Inc. · Oct 9, 2025 · K253094

FDA cleared the iFuse Bedrock Granite Implant System from SI-BONE, Inc. on Oct 9, 2025 under K253094, a special 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 Sep 23, 2025. The decision came 16 days later, inside the 90 FDA-day goal for a 510(k).

SI-BONE, Inc. has 2 other decisions in the tracker over the last 12 months: K253488 (iFuse INTRA Ti Implant System), K251780 (iGPS Navigation Instruments).

Questions & Answers

What did FDA clear under K253094?

K253094 is the FDA 510(k) for iFuse Bedrock Granite Implant System, submitted by SI-BONE, Inc.. FDA's decision date was Oct 9, 2025, under product code OUR (Sacroiliac Joint Fixation).

Who makes the iFuse Bedrock Granite Implant System?

SI-BONE, Inc., based in Santa Clara, CA, is the applicant of record for K253094.

How long did the K253094 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Oct 9, 2025, 16 days later.

← All decisions in October 2025

Sources