Biopor AOC Porous Polyethylene Cerepor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160988 FDA 510(k)
- FDA Product Code
- KKY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3500 FDA 510(k)
- Regulation Number
- 878.3500 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Biopor AOC Porous Polyethylene Cerepor is a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, classified under FDA regulation 878.3500. It is designed as a porous polyethylene implant intended for maxillofacial augmentation or reconstruction, available in block, sheet, and anatomical shapes.
The device is supplied in sterile form and is intended for single-use. It is approved under a Traditional 510(k) clearance (K160988) with a Substantially Equivalent (SESE) determination by the FDA’s General Plastic Surgery Advisory Committee. Available sizes and anatomical forms are referenced in the registration numbers (e.g., 1032347, 3014680740, etc.).
Frequently asked questions
What types of maxillofacial procedures is the Biopor AOC Porous Polyethylene Cerepor implant designed for?
The Biopor AOC Porous Polyethylene Cerepor is specifically designed for maxillofacial augmentation or reconstruction, providing structural support in procedures where bone grafting or contouring is required. Its porous polyethylene composition allows for tissue integration, making it suitable for applications like facial contouring, orbital reconstruction, or mandibular augmentation.
Is the Biopor implant available in multiple shapes and sizes, and how are they specified?
Yes, the Biopor implant comes in block, sheet, and anatomical shapes to accommodate various surgical needs. Sizes and anatomical forms are referenced by specific registration numbers (e.g., 1032347, 3014680740), which correspond to distinct configurations. These numbers help clinicians identify the exact dimensions and formality required for their procedure.
How is the Biopor implant supplied, and what does that mean for surgical workflow?
The Biopor implant is supplied in sterile form, ensuring immediate readiness for single-use in the operating room. This eliminates the need for sterilization between cases, streamlining workflow and reducing contamination risks. Since it’s intended for single-use only, each package is designed for one surgical procedure.
What regulatory pathway was followed for FDA clearance of the Biopor implant?
The Biopor implant received FDA clearance via a Traditional 510(k) pathway (K160988), with a Substantially Equivalent (SESE) determination by the FDA’s General Plastic Surgery Advisory Committee. This means the device was deemed comparable to a legally marketed predicate in terms of safety and effectiveness for maxillofacial reconstruction.
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: Biopor, AOC Porous Polyethylene, Cerepor (K160988) — FDA 510 (k ..., Biopor, AOC Porous Polyethylene, Cerepor 510(k) K160988 - fda.report, FDA Browser - Cleared 510 (K) - BIOPOR AOC POROUS POLYETHYLENE, CEREPOR ..., Biopor, AOC Porous Polyethylene, Cerepor — FDA K160988
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160988 | Class II | Active |
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Manufacturer
- Manufacturer
- Ceremed , Inc.
Sources (1)
- FDA 510(k) K160988 24 fields · synced Sep 19, 2026