Cleared Traditional

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

K251441 · Inion OY · Dental

Nov 2025

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K251441 is an FDA 510(k) clearance for the Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on November 7, 2025, 182 days after receiving the submission on May 9, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number	K251441 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2025
Decision Date	November 07, 2025
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF