SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152463 FDA 510(k)
- FDA Product Code
- FWP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3550 FDA 510(k)
- Regulation Number
- 878.3550 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SU-POR Patient-Specific Cranial and Facial Implants are custom-designed, patient-specific prostheses classified as internal chin prostheses. These devices are fabricated from biocompatible porous polyethylene and are engineered to reconstruct or augment craniomaxillofacial structures, providing structural support and integration with surrounding tissue through an interconnected pore structure.
These implants are intended for non-weight-bearing applications in craniofacial reconstruction or cosmetic procedures. Supplied as single-use devices, they require sterile packaging and are regulated under FDA 510(k) clearance (K152463) as substantially equivalent to predicate devices. The implants are tailored to individual patient anatomy and are available in custom shapes as specified by surgical requirements, with no noted MRI safety restrictions in the provided data.
Frequently asked questions
Are these implants reusable or designed for single-use only, and how should they be handled before surgery?
The SU-POR Patient-Specific Cranial and Facial Implants are explicitly designed as single-use devices. They come in sterile packaging to ensure safety and efficacy for one surgical procedure only. Since they are custom-fabricated for individual patients, they should never be reused or reprocessed, as this could compromise sterility, structural integrity, or biocompatibility. Always follow the manufacturer’s instructions for handling to maintain sterility before use.
What materials are these implants made from, and how does that affect their integration with the body?
The implants are fabricated from biocompatible porous polyethylene, a material engineered to promote osseointegration and soft tissue ingrowth through its interconnected pore structure. This design allows surrounding bone and tissue to grow into the implant, providing long-term stability and reducing the risk of rejection or loosening. The porosity is specifically tailored to support non-weight-bearing craniofacial reconstruction or cosmetic augmentation.
Can these implants be used for both cranial and facial reconstruction, or are there specific models for each?
The SU-POR implants are custom-designed for both cranial and facial applications, meaning they are not limited to one anatomical region. Each implant is patient-specific, shaped precisely to match the individual’s surgical requirements—whether reconstructing cranial defects, augmenting facial structures, or addressing maxillofacial deformities. The exact shape and dimensions are determined collaboratively with the surgeon based on preoperative imaging.
Are there any restrictions on using these implants with MRI machines, and if so, why?
The provided data does not mention any MRI safety restrictions for the SU-POR implants. However, since they are made from porous polyethylene, it’s always advisable to confirm compatibility with your MRI machine’s manufacturer before use. If concerns arise, consult the device’s technical documentation or Poriferous, LLC for guidance, as material properties (e.g., metallic components or ferromagnetic impurities) could theoretically affect imaging in rare cases.
How are these implants ordered, and do they come in standard sizes or are they fully custom-made?
These implants are fully custom-made and not available in standard sizes. The fabrication process begins with preoperative imaging (e.g., CT scans) of the patient’s anatomy, which is sent to Poriferous, LLC to design and produce the implant. The surgeon specifies the exact shape, dimensions, and placement parameters, ensuring the implant fits the patient’s unique surgical needs. Orders are not stocked; each implant is tailored to individual cases.
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: Patient-Specific Implants - Poriferous, Poriferous Su-Por Implants | Poriferous, SU-POR® | Poriferous - imsco-ph.com, SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152463 | Class II | Active |
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Manufacturer
- Manufacturer
- Poriferous, LLC
Sources (1)
- FDA 510(k) K152463 24 fields · synced Oct 6, 2026