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

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251472

by Inion Oy

Identifiers

510(k) Number
K251472 FDA 510(k)
FDA Product Code
HBW FDA 510(k)
Models / Variants
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System FDA 510(k)
Inion CPS 1.5 Baby Bioabsorbable Fixation System FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5360 FDA 510(k)
Regulation Number
882.5360 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System is a bioabsorbable fixation device classified as a Fastener, Plate, Cranioplasty. It consists of degradable fixation plates, meshes, and screws designed for cranial and midface reconstruction, providing mechanical stability during bone healing. The system utilises co-polymers of L-lactic acid, D-lactic acid, and trimethylene carbonate, which degrade via hydrolysis into metabolisable alpha-hydroxy acids.

This system is intended for single-use in trauma or reconstructive procedures within the craniofacial and midface regions. Supplied sterile, the components are bioabsorbable with mechanical strength retention of 70% after nine weeks and a bioresorption timeframe of two to four years. The device is authorised under FDA 510(k) clearance (K251472) and falls under Class II regulatory classification (21 CFR 882.5360). Storage and handling follow standard sterile medical device protocols.

Frequently asked questions

What types of surgical procedures is the Inion CPS Bioabsorbable Fixation System designed for?

The Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System is specifically designed for cranial and midface reconstruction in trauma or reconstructive procedures. Its bioabsorbable plates, meshes, and screws provide mechanical stability during bone healing in these regions, ensuring secure fixation while the bone regenerates.

How long does it take for the fixation components to degrade after implantation?

The system’s bioabsorbable materials degrade over a timeframe of two to four years through hydrolysis. During this period, the device retains 70% of its mechanical strength after nine weeks, ensuring stability during the critical early stages of bone healing.

Is the Inion CPS system intended for reuse, or is it meant to be used only once?

The Inion CPS Bioabsorbable Fixation System is explicitly designed for single-use only. This aligns with standard sterile medical device protocols to prevent contamination and ensure patient safety during surgical procedures.

What materials are used in the Inion CPS Bioabsorbable Fixation System, and how do they break down?

The system uses co-polymers of L-lactic acid, D-lactic acid, and trimethylene carbonate, which degrade via hydrolysis into metabolizable alpha-hydroxy acids. This gradual breakdown ensures the device maintains structural integrity during bone healing before fully dissolving.

How should the Inion CPS system be stored, and what precautions should be taken?

The system is supplied sterile, so storage must follow standard sterile medical device protocols to preserve integrity. This includes maintaining dry conditions, protecting from physical damage, and adhering to manufacturer guidelines to prevent contamination before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Inion - Products - CPS™ Bioabsorbable Fixation System for CMF, PDF Microsoft Word - IFU CPS 12000020 rev 18 2023-02-01.docx - Inion, Inion CPS™ - Bioabsorbable Fixation System - MedicalExpo

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inion Oy

Sources (1)

  • FDA 510(k) K251472 24 fields · synced Sep 19, 2026