Inion CPS Baby 1.5 Bioabsorbable Fixation System
FDA 510(k)Class II (US FDA 510(k))
by Inion , Ltd.
Identifiers
- 510(k) Number
- K010351 FDA 510(k)
- FDA Product Code
- JEY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4760 FDA 510(k)
- Regulation Number
- 872.4760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Inion CPS Baby 1.5 Bioabsorbable Fixation System is a device containing resorbable plates, meshes and screws made of degradable co-polymers composed of L-lactic acid, glycolic acid and trimethylene carbonate. These polymers degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The system is designed for use in the craniofacial skeleton for trauma and reconstructive procedures.
The system is supplied as a selection of plates, meshes and screws in different shapes and sizes. It is a Class II device cleared by the FDA through a 510(k) process with the product code JEY. The device is intended for single-use and should be stored according to the manufacturer's instructions.
Frequently asked questions
What is the Inion CPS Baby 1.5 Bioabsorbable Fixation System used for?
The system is designed for use in the craniofacial skeleton for trauma and reconstructive procedures. It contains resorbable plates, meshes and screws made of degradable co-polymers that break down in the body over time.
Is the Inion CPS Baby 1.5 Bioabsorbable Fixation System reusable or single-use?
The device is intended for single-use only. After being used in a surgical procedure, it should not be reused on another patient. Proper disposal following medical waste protocols is required after single use.
How should the Inion CPS Baby 1.5 Bioabsorbable Fixation System be stored?
The system should be stored according to the manufacturer's instructions. While specific storage conditions aren't detailed in the provided information, medical devices typically require storage in a controlled environment away from extreme temperatures, moisture, and direct sunlight.
What is the regulatory status of the Inion CPS Baby 1.5 Bioabsorbable Fixation System?
The device is a Class II device cleared by the FDA through a 510(k) process with the product code JEY. It has been determined to be substantially equivalent to predicate devices for its intended use in craniofacial fixation procedures.
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 12000085 (4/110203) - Inion, Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby ..., Inion Cps Baby 1.5 Bioabsorbable Fixation System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010351 | Class II | Active |
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Manufacturer
- Manufacturer
- Inion , Ltd.
Sources (1)
- FDA 510(k) K010351 24 fields · synced Sep 23, 2026