MEDPOR CONTAIN IMPLANT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, black letters. Below the word "POREX" is the phrase "SURGICAL PRODUCTS GROUP" in smaller, black letters. The logo is simple and professional. K091120 MAR 1 9 2010 # 510(k) SUMMARY Date of Summary: March 11, 2010 ### Manufacturer and Submitter: Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265 Tel: (678) 479-1610 Fax: (678) 479-4495 Contact: Mrs. Jerri Mann E-mail: jerri.mann@porex.com Trade Name: MEDPOR® CONTAIN™ Implant Class: II, 21 CFR 872.3930 Bone grafting material Product Code: NPK ## Substantially equivalent to: 1) MEDPOR® Surgical Implant Material; Preformed Cranial & Facial Implants, K922489 2) GORE RESOLUT® ADAPT Regenerative Membrane, K051267 3) Osteo-Mesh TM-300 (Titanium Ridge Augmentation Mesh), K984230 4) Cytoplast™ Regentex Titanium 250, K972278 5) IMTEC/Titanium Mesh, K970841 ### Device Description: MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocompatible pure porous high-density polyethylene (pHDPE) material which allows for host tissue integration as other MEDPOR Surgical Implants. The MEDPOR CONTAIN Implant is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing. ### Indications for Use: The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible, and zygoma. ર - I {1}------------------------------------------------ ## Technological Characteristics: The MEDPOR CONTAIN Implant can be used to contain, support and maintain the space for bone graft material that is used in the maxilla, mandible or zygoma to reestablish missing bone or establish new bone for support of dental implants. The MEDPOR CONTAIN Implant can be trimmed or cut to size and bent to conform to the needs of the individual patient. It may be stabilized with tacks, sutures, wires, or craniofacial screws. The MEDPOR CONTAIN Implant is manufactured from the same material, packaged, labeled and sterilized the same as all other MEDPOR Surgical Implant Material: Preformed Cranial and Facial Implants. ## Substantial Equivalence: The MEDPOR CONTAIN Implant shares indications and design principles with the following predicate devices: | Device Name | Proposed<br>Device | Predicate<br>Device #1 | Predicate<br>Device #2 | Predicate<br>Device #3 | Predicate<br>Device #4 | Predicate<br>Device #5 | |------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | | MEDPOR<br>CONTAIN<br>Implant | MEDPOR<br>Surgical Implant<br>Material;<br>Preformed<br>Cranial & Facial<br>Implants | GORE<br>RESOLUT<br>ADAPT<br>Regenerative<br>Membrane | Osteo-Mesh TM-<br>300 (Titanium<br>Ridge<br>Augmentation<br>Mesh) | IMTEC/Titanium<br>Mesh | Cytoplast<br>Regnetex<br>Titanium 250<br>(Titanium Ridge<br>Augmentation<br>Mesh | | 510(k)<br>Number | This<br>Submission | K922489 | K051267 | K984230 | K970841 | K972278 | | Intended Use | The MEDPOR<br>CONTAIN<br>Implant is<br>intended to<br>stabilize, support<br>and provide<br>space<br>maintenance for<br>bone graft<br>materials in the<br>maxilla,<br>mandible, and<br>zygoma. | For augmentation<br>or restoration of<br>bony contour in<br>craniofacial<br>defects. | For use during<br>the process of<br>guided bone<br>regeneration as a<br>bioabsorbable<br>membrane for<br>supporting:<br>augmentation<br>around<br>immediately<br>placed<br>endosseous<br>implants or<br>existing<br>endosseous<br>implants (e.g.,<br>dehiscence and<br>fenestration<br>defects,<br>extraction<br>sockets); ridge<br>augmentation for<br>later implantation<br>of endosseous<br>implants; and<br>sinus procedures<br>(e.g., sinus<br>window, sinus<br>lift). | For stabilization<br>and support of<br>bone grafts in<br>dento-alveolar<br>bony defect sites. | For the repair of<br>both localized<br>and extensive<br>alveolar ridge<br>defects,<br>protection for the<br>graft site,<br>membrane<br>support, tissue<br>support. | A temporarily<br>implantable<br>material (non-<br>resorbable) for<br>use as a space-<br>making barrier in<br>the treatment of<br>periodontal<br>defects. | | Material | A linear, high-density<br>polyethylene<br>biomaterial | A linear, high-density<br>polyethylene<br>biomaterial | Synthetic<br>resorbable<br>copolymer<br>materials | Grade 1 Titanium | Expanded CP<br>Titanium | A nonporous high<br>density<br>polytetrafluoroet<br>hylene film<br>enforced with a<br>titanium | {2}------------------------------------------------ | Design | 15mm x 30mm,<br>25mm x 30mm,<br>45mm x 30mm<br>sheets in 0.25mm<br>and 0.35mm<br>thicknesses and<br>other shapes and<br>sizes as well as<br>patient specific<br>customized<br>shapes | Preformed<br>shapes including<br>sheets, micro thin<br>sheets and ultra<br>thin sheets | Regenerative<br>membrane 15mm<br>x 20mm, 20mm x<br>25mm and 25mm<br>x 30mm | Ti nitride coated<br>perforated mesh<br>0.009 inch thick<br>25mm x 30mm,<br>and<br>12mm x 25mm | 34mm x 25mm<br>0.10mm<br>thickness | 0.25 mm thick<br>25mm x 30mm,<br>12mm x 25mm,<br>14mm x 20mm,<br>14mm x 24mm,<br>20mm x 25mm,<br>13mm x 19mm<br>and 13mm x<br>18mm | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Sterile/<br>Non-Sterile | Sterile | Sterile | Sterile | Non-Sterile | Sterile | Sterile | | Sterilization<br>Method | EtO | EtO | Gamma | Autoclave | Not specified | Steam | | Biocompatible | Yes | Yes | Yes | Yes | Yes | Yes | . {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Jerri L. Mann Regulatory Compliance Manager Porex Surgical, Incorporated 15 Dart Road Newnan, Georgia 30265 MAR 1 9 2010 Re: K091120 Trade/Device Name: MEDPOR® CONTAIN™ Implant Regulation Number: 21CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: March 11, 2010 Received: March 12, 2010 Dear Ms. Mann: 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, listing 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. {4}------------------------------------------------ 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. 1- for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 09/120 Indications for Use 510(k) Number: K091120 Device Name: MEDPOR® CONTAIN™ Implant Indications for Use: The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma. 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices 510(k) Number: K09112 Page 1 of 1