Inion CPS Baby 1.5 Bioabsorbable System
FDA 510(k)Class II (US FDA 510(k))
by Inion , Ltd.
Identifiers
- 510(k) Number
- K033194 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 System is a bone plate, absorbable (OpenFDA classification) designed for pediatric craniomaxillofacial applications. It consists of fixation plates, meshes, and screws fabricated from degradable co-polymers of L-lactic acid, glycolic acid, and trimethylene carbonate. These materials are engineered to hydrolyze in vivo into alpha-hydroxy acids, which are subsequently metabolized by the body. The system is intended for use in trauma and reconstructive procedures within the craniofacial skeleton.
This device is supplied as a sterile, single-use system for surgical fixation in pediatric patients. It is classified as a Class II medical device under FDA regulations (21 CFR 872.4760) and holds a 510(k) clearance from the FDA. The system’s components are intended for one-time use and are not reusable. No specific MRI safety labeling is provided, and storage conditions must adhere to manufacturer guidelines to maintain sterility and integrity. The product is authorized under the registration number K033194 and associated FEI numbers.
Frequently asked questions
What is the Inion CPS Baby 1.5 Bioabsorbable System used for?
This system is designed specifically for pediatric craniomaxillofacial applications, including trauma and reconstructive procedures within the craniofacial skeleton. Its bioabsorbable components provide temporary internal fixation, dissolving over time into alpha-hydroxy acids that the body metabolizes naturally. This avoids the need for secondary removal surgery, making it ideal for children whose bones are still growing.
How is the Inion CPS Baby 1.5 system supplied and prepared for use?
The system is supplied sterile and intended for single-use only. Each component—plates, meshes, and screws—is pre-packaged to maintain sterility until surgical use. It is not reusable, and proper handling per manufacturer guidelines is required to preserve sterility and structural integrity before implantation.
What materials are used in the Inion CPS Baby 1.5 Bioabsorbable System, and how do they degrade?
The system is fabricated from degradable co-polymers of L-lactic acid, glycolic acid, and trimethylene carbonate. These materials hydrolyze in vivo, breaking down into alpha-hydroxy acids that the body metabolizes as part of its natural processes. This gradual degradation ensures the plate maintains stability during bone healing before fully dissolving.
Are there specific storage requirements for this device?
Yes, storage must adhere strictly to manufacturer guidelines to preserve sterility and structural integrity. The system should be stored in its original packaging, protected from moisture, extreme temperatures, and physical damage. Improper storage could compromise the device’s performance or sterility before use.
Does the Inion CPS Baby 1.5 system have any MRI safety labeling?
No specific MRI safety labeling is provided for this system. Clinicians should consult the manufacturer’s instructions for use and consider potential risks before using MRI imaging with implanted components. Always verify compatibility with imaging modalities pre-procedure.
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 BABY 1.5 BIOABSORBABLE SYSTEM (K033194) — FDA 510 (k ..., 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 | K033194 | Class II | Active |
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Manufacturer
- Manufacturer
- Inion , Ltd.
Sources (1)
- FDA 510(k) K033194 24 fields · synced Oct 1, 2026