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 / November 2025 / K251441

510(k) cleared

Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

Inion OY · Nov 7, 2025 · K251441

FDA cleared the Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System from Inion OY on Nov 7, 2025 under K251441, a traditional 510(k). The device falls under product code JEY, Plate, Bone, regulated at 21 CFR 872.4760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on May 9, 2025. The decision came 182 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Inion OY in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251441?

K251441 is the FDA 510(k) for Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System, submitted by Inion OY. FDA's decision date was Nov 7, 2025, under product code JEY (Plate, Bone).

Who makes the Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System?

Inion OY, based in Tampere, is the applicant of record for K251441.

How long did the K251441 review take?

FDA received the submission on May 9, 2025 and issued its decision on Nov 7, 2025, 182 days later.

← All decisions in November 2025