SU-POR SURGICAL IMPLANT

K140437 · Poriferous, LLC · KKY · Jun 13, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140437
• Device Name: SU-POR SURGICAL IMPLANT
• Applicant: Poriferous, LLC
• Product Code: KKY · General, Plastic Surgery
• Decision Date: Jun 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Su-Por® Surgical Implants in block, sheet, and anatomical shapes are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. Su-Por® Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

Device Story

Su-Por® Surgical Implants are porous high-density polyethylene (HDPE) implants designed for non-weight bearing craniofacial reconstruction and augmentation. The device features an interconnecting open-pore structure that facilitates tissue ingrowth. Implants are provided in various preformed shapes, including sheets, blocks, spheres, and anatomical configurations. Used by surgeons in clinical settings for trauma repair or cosmetic skeletal restoration. The device is single-use and provided sterile via ethylene oxide (EtO). Implants are placed surgically to restore or augment skeletal contours, providing a stable scaffold for tissue integration.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993 standards), mechanical performance (impact, flexural, tensile strength, purity, and porosity), and sterilization validation.

Technological Characteristics

Material: Linear high-density polyethylene (HDPE) with interconnecting open-pore structure. Form factor: Preformed sheets, blocks, spheres, and anatomical shapes. Sterilization: Ethylene oxide (EtO). Packaging: Double Tyvek pouch. Non-reusable.

Indications for Use

Indicated for patients requiring non-weight bearing craniofacial reconstruction, cosmetic surgery, repair of craniofacial trauma, or augmentation/restoration of craniomaxillofacial skeletal contour.

Regulatory Classification

Identification

A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

Predicate Devices

• MEDPOR® Surgical Implant Material: Preformed Cranial and Facial Implants (K922489)
• OmniPor® Surgical Implants (K123908)

Submission Summary (Full Text)

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# Poriferous, .LLC

Office: 770-683-3855 Fax: [phone]

K140437

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### 510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.

- Submitted By: Poriferous, LLC 535 Pine Road, Suite 206, Newnan Georgia, 30263-7640 Phone: [phone] Fax: [phone]
- Contact Person: Aaron Noble, President/CEO Poriferous, LLC, Inc
- Date Prepared: January 10th 2014

#### Device Name and Classification:

| Trade/Proprietary Name: | Su-Por® Surgical Implants |
|----------------------------|---------------------------------------------------|
| Common Name: | Porous HD Polyethylene (HDPE) Implants |
| Classification Name: | Ear, Nose, and throat synthetic polymer material. |
| Class: | II |
| Regulation: | 21 CFR 878.3500, |
| Product Code: | KKY |
| Subsequent<br>Product Code | FWP |

#### Legally Marketed Predicate Devices:

POREX Surgical INC. (now owned by Stryker® Craniomaxillofacial) MEDPOR® Surgical Implant Material: Preformed Cranial and Facial Implants - 510(k) # K922489

Matrix Surgical USA OmniPor® Surgical Implants -- 510(k) #K123908

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#### Device Description:

The Su-Por® Surgical Implants are marketed as single use sterile implants with various shapes and sizes for different areas of the craniofacial skeleton. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton.

The raw material used for the Su-Por® Surgical Implants is high-density polvethylene when molded into the implants becomes a porous high-density polyethylene. Polvethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the Su-Por® Surgical Implants allow for tissue in growth. The material used to manufacture the Su-Por® Surgical Implants has been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene implants for enucleation and evisceration, as well as for many applications in craniofacial reconstruction and augmentation, with a history of safety and performance. The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.

#### Indications for Use:

Su-Por® Surgical Implants in block, sheet, and anatomical shapes are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. Su-Por® Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

#### Similarities and Differences to the Predicate Devices:

The same raw materials, manufacturing processes, packaging materials, performance standards, and the same indications for use are used in the Su-Por and the predicate devices.

The following table provides a comparison of the proposed device, and the predicate devices;

| Device Name | Proposed Device | Predicate #1 | Predicate #2 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | Su-Por® Surgical<br>Implants; Preformed<br>block, sheet, and<br>anatomical shapes. | MEDPOR®<br>Surgical Implant<br>Material; Preformed<br>Cranial & Facial<br>Implants | OmniPor® Surgical<br>Implants; Preformed<br>block, sheet, and<br>anatomical shapes. |
| 510(k) Number<br>Intended Use | This Submission<br>Su-Por® Surgical<br>Implants in block, sheet,<br>and anatomical shapes<br>are intended for non- | K922489<br>For augmentation<br>or restoration bony<br>contour in<br>craniofacial | K123908<br>OmniPor® Surgical<br>Implants in block,<br>sheet, and anatomical<br>shapes are intended for |

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## Poriferous, .LLC

Office: 770-683-3855 Fax: [phone]

K140437 Page 3 of 4

| | weight bearing<br>applications of<br>craniofacial<br>reconstruction/cosmetic<br>surgery and repair of<br>craniofacial trauma. Su-<br>Por® Surgical Implants<br>are also intended for the<br>augmentation or<br>restoration of contour in<br>the craniomaxillofacial<br>skeleton. | defects. | nonweight bearing<br>applications of<br>craniofacial<br>reconstruction/cosmetic<br>surgery and repair of<br>craniofacial trauma.<br>OmniPore Surgical<br>Implants are also<br>intended for the<br>augmentation or<br>restoration of contour in<br>the craniomaxillofacial<br>skeleton. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | A linear, high-density<br>polyethylene biomaterial | A linear, high-<br>density<br>polyethylene<br>biomaterial | A linear, high-density<br>polyethylene<br>biomaterial |
| Design | Preformed shapes<br>including sheets, blocks,<br>spheres, and<br>anatomical shapes. | Preformed shapes<br>including sheets,<br>blocks, spheres,<br>and anatomical<br>shapes. | Various shapes and<br>sizes for differing areas<br>of the craniofacial<br>skeleton. |
| Sterile / Non-<br>Sterile | Sterile | Sterile | Sterile |
| Sterilization<br>Method | EtO | EtO | EtO |
| Packaging | Double Tyvek Pouch | Double Tyvek<br>Pouch | Double Tyvek Pouch |
| Biocompatible | Yes | Yes | Yes |
| Reusable | No | No | No |

#### Summary of Testing:

The Su-Por Surqical Implants were tested to the biocompatibility standards to demonstrate that they are substantially equivalent materials as the predicate devices in regards to Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study. The Su-Por Surgical Implants completed sterilization validate that that they are sterile devices for implantation as equivalent to the predicate devices. The Su-Por Surgical Implants completed mechanical testing specific to impact testing, flexural testing, tensile strength testing, purity testing per USP, and porosity testing.

The testing listed above assures the device is safe and effective for its intended use.

#### Substantial Equivalence Conclusions:

The Su-Por® Surgical Implants have the same intended use and indications for use, and the same technological characteristics and principles of operation as

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the predicate devices. It is concluded that the proposed device is substantially equivalent, based on the nonclinical testing (discussed above) that demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing care and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is rendered in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Poriferous, LLC Mr. Aaron Noble President/Chief Executive Officer 535 Pine Road. Suite 206 Newnan, Georgia 30263

June 13, 2014

Re: K140437

Trade/Device Name: Su-Por Surgical Implant Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY, FWP Dated: May 12, 2014 Received: May 16, 2014

Dear Mr. Noble:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Aaron Noble

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Neil R Ogden -S 2014.06.13 13:53:53 -04'00'

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Statement of Indications for Use

Applicant: Poriferous, LLC.

510(k) Number (if known): K140437

Device Name: Su-Por Surgical Implant

Indications for Use:

Su-Por Surgical Implants in block, sheet, and anatomical shapes are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. Su-Por Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter L. Hudson -S