OSTEON III

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 14, 2016 Genoss Co., Ltd. Eunsang Lee Manager 1F Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu Suwon-si, Gyeonggi-do, 433-270 KR Re: K153676 Trade/Device Name: OSTEON III Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: August 8. 2016 Received: August 15, 2016 Dear Eunsang Lee: 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. 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 (800) 638-2041 or (301) 796-7100 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" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Michael J.DRyan -S for Tina Kiang, PhD Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K153676 Device Name OSTEON III Indications for Use (Describe) OSTEON III is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. - Periodontal/infrabony defects - Ridge augmentation - Extraction Sites(implant preparation/ placement) - Sinus lifts - Cystic cavities Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Company | | Submitter | |----------------|--------------------------------------------------------------------------------------------------| | Name | GENOSS Co., Ltd. | | Address | 1F Gyeonggi R&DB center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si,<br>Gyeonggi-do, 433-270, Korea | | Phone/Fax | +82-31-888-5100/ +82-31-888-5595 | | Contact person | Eunsang Lee / RA<br>eslee@genoss.com | | Summary Date | 14th September, 2016 | # 2. Device Name | Proprietary name: | OSTEON III | |----------------------|-----------------------------------| | Common name: | Bone grafting material | | Classification name: | Bone grafting material, Synthetic | | Product Code: | LYC | | Regulation: | 21 CFR 872.3930 | # 3. Predicated Device | K051885 | MBCP (Primary) | |---------|--------------------------------| | K040646 | Straumann Granules (Reference) | # 4. Description This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (ß-TCP). This product presents an interconnected porous structure, similar to that human cancellous bone. This product is available as irregular shape particle of size 0.2~2.0mm. It is sterilized by gamma-radiation. #### 510(k) Summary {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "GENOSS" in green font. The first half of the word is a darker green, while the second half is a lighter green. Below the word is the text "5. Indication for use" in a bold, black font. OSTEON III is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. - Periodontal/infrabony defects - Ridge augmentation - Extraction Sites(implant preparation/ placement) - Sinus lifts - Cystic cavities # 6. Technological Characteristics OSTEON III has the similar technological characteristics as the predicated device; main material, intended use, device design, composition of Materials, physical properties is as following. | Device name | OSTEON III | MBCP | Straumann Granules | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | GENOSS | Biomatlante | Straumann | | 510(k) Number | New Device | K051885 | K040646 | | Intended Use | | | | | Indication for Use | -Periodontal/<br>Infrabony defects<br>- Ridge augmentation<br>-Extraction sites<br>(implant preparation /<br>placement)<br>- Sinus lifts | - Osteogenic scaffold<br>for bone healing<br>- Promotes<br>osteoblastic<br>proliferation and<br>differenciation.<br>- Stimulates the<br>osteoblastic response. | - Sinus lift<br>- Bony defects of the<br>alveolar ridge<br>- Intraosseous defects<br>- Peri-implant defects<br>- Extraction sockets | | Applicable | Human Oral, periodontal | | | | Function | Osteoconductive | | | | Device Design | | | | | Physical morphology | Interconnecting<br>macro and micro pores | | | | Performance | Bone formation | | | | Surgical site | Oral, Periodontal | | | | Package | Glass vial,<br>Glass syringe | Glass, Plastic vial<br>Glass syringe | Glass, Plastic vial | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter, lime green color. The font appears to be sans-serif and slightly rounded, giving the word a modern and clean look. | Composition of Materials | | | | |----------------------------------|------------------------------------------------|---------------------|---------------------| | Composition | Biphasic Calcium Phosphate (HA 60%+ β-TCP 40%) | | | | Physical Properties | | | | | Bone material | Synthetic bone | | | | Phase | Biphasic (HA+ β-TCP) | | | | Porosity | ~80% | ~70% | ~90% | | Pore size | 200~400 μm | 300~600 μm | 100~500 μm | | Particle of Size | 0.2~2.0mm | 0.5~2.0mm | 0.4~1.0mm | | Ca/P | 1.59 | 1.6 | 1.61 | | Crystalline phase<br>composition | HA 60%: | HA 60%: | HA 60%: | | Crystallinity | > 70% | > 70% | > 70% | | Elution-pH | pH difference ≤ 1.5 | pH difference ≤ 1.5 | pH difference ≤ 1.5 | | Others | | | | | Biocompatible | Biocompatible | | | | Sterilization | Gamma Irradiation | | | | Shelf life | 1.5 years | | | #### 7. Performance Data Biocompatibility testing on the proposed OSTEON III has been completed. Requirements for biological evaluation of the proposed device were based on the Blue Book memorandum G95-1 issued on May 1, 1995, Use of International Standard ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed: - -ISO Cytotoxicity -ISO Sensitization -ISO Pyrogencity -ISO Intracutaneous reactivity -ISO Systemic toxicity -ISO Subchronic toxicity -ISO Genotoxicity-Ames -ISO Genotoxicity-Micro nucleus -ISO Implantation -ISO Genotoxicity-Chromosomal aberration -ISO Endotoxin (LAL) #### 510(k) Summary {6}------------------------------------------------ The proposed OSTEON III was evaluated using the following performance bench testing to confirm the performance characteristics: | - Visual Test | - Size | |----------------------------------------|-----------------------------------| | - Capacity | - Density | | - Trace Elements | - Ca/P ratio | | - Crystalline phase Composition | - Crystallinity | | - Morphology & Surface Characteristics | - Water Solubility | | - Elution Test (pH, Pb) | - Potassium permanganate consumed | | - Ultraviolet rays absorption spectrum | - Resorption | | - Particle size distribution | - Compressive strength | | - Shear and Elastic modulus | | All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON III met the established specifications necessary for consistent performance according to its intended use. ### 8. Substantial Equivalence While the Indications for Use statements for the proposed and predicate devices differ, their meaning is equivalent as they share the same intended use, namely to serve as a bone grafting material to fill, augment or reconstruct various types of periodontal or oral/maxillofacial defects. The primary difference between OSTEON III and its primary predicate device MBCP (K051885) is related to slight mechanical and physical characteristics, such as small differences in pore and particle sizes. The proposed device features a pore size slightly lower than that available in the primary predicate device. However, a reference predicate is provided which features a range of pore sizes capturing those of the proposed device. Similarly, the proposed device features particle size which is slightly lower than that of the primary predicate. However, additional nonclinical testing results demonstrate that the any differences noted between OSTEON III and its predicate devices do not raise new concerns. ### 9. Conclusion Based on the information provided in this premarket notification of GENOSS Co., Ltd. conclude that OSTEON III is substantially equivalent to its predicate devices. #### 510(k) Summary