Cleared Traditional

K251472 - Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

Also marketed or referenced as:
Inion CPS 1.5 Baby Bioabsorbable Fixation System

K251472 is an FDA 510(k) clearance for Inion CPS 1.5/2.0/2.5 Bioabsorbable Fix..., manufactured by Inion OY. The device is a Class 2 Neurology device with product code HBW cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K251472 · Inion OY · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
59d
Days
Class 2
Risk

K251472 is an FDA 510(k) clearance for the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System. Classified as Fastener, Plate, Cranioplasty (product code HBW), Class II - Special Controls.

Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on July 11, 2025 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5360 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Inion OY devices

FDA 510(k) Submission Details - K251472

510(k) Number K251472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2025
Decision Date July 11, 2025
Days to Decision 59 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 149d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBW Device Classification - Class 2, Special Controls

Product Code HBW Fastener, Plate, Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBW Fastener, Plate, Cranioplasty

Devices cleared under the same product code (HBW) and FDA review panel - the closest regulatory comparables to K251472.
Stryker Resorbable Fixation System
K231208 · Stryker Leibinger GmbH & Co KG · Aug 2023
Stryker Universal Neuro III System AXS Screw
K171152 · Stryker · May 2017
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
K151387 · Stryker · Jun 2015
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
K141385 · Depuy Synthes Companies of Johnson & Johnson · Mar 2015
MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
K101835 · Porex Surgical, Inc. · Dec 2010
MEMOGRAPH
K001353 · Biomedical Ent., Inc. · Mar 2001