OSTEON II

K112716 · Genoss Co., Ltd. · LYC · Jan 17, 2012 · Dental

Device Facts

• Record ID: K112716
• Device Name: OSTEON II
• Applicant: Genoss Co., Ltd.
• Product Code: LYC · Dental
• Decision Date: Jan 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSTEON II 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

Device Story

OSTEON II is a synthetic, osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). It features an interconnected porous structure mimicking human cancellous bone. Supplied as irregular particles (0.2–2.0 mm) and sterilized via gamma irradiation. Used by clinicians in dental or oral/maxillofacial surgical settings to fill or reconstruct bone defects. The material acts as a scaffold to support bone regeneration. Clinical benefit is derived from its osteoconductive properties, facilitating the repair of periodontal and oral defects.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 standards, including cytotoxicity, pyrogenicity, intracutaneous reactivity, Ames test, systemic toxicity, sensitization, implantation, and micro-nucleus tests. Performance bench testing confirmed Ca/P ratio, crystalline phase composition, porosity, water solubility, density, and crystallinity values met established specifications.

Technological Characteristics

Synthetic bone graft material; composition: 55-75wt% HA and 25-45wt% B-TCP; particle size: 0.2-2.0 mm; interconnected porous structure; sterilization: gamma irradiation.

Indications for Use

Indicated for patients requiring bone grafting to fill, augment, or reconstruct periodontal or oral/maxillofacial defects, including infrabony defects, ridge augmentation, extraction sites, sinus lifts, and cystic cavities.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• OSTEON (K062834)

Submission Summary (Full Text)

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K112716

JAN 1 7 2012

## CEMOZZ

## 510(k) Summary

12/26/2011

## 1. Company

| | Submitter |
|----------------|-------------------------------------------------------------------------------------------------|
| Name | GENOSS Co., Ltd. |
| Address | 1F Gyeonggi R&DB center, 906-5 Iui-dong, Suwon-si, Yeongtong-gu,<br>Gyeonggi-do, 433-270, Korea |
| Phone/Fax | [phone]/ [phone] |
| Contact person | Sungwon Lee / QA<br>[e-mail] |
| Summary Date | September 14, 2011 |

## 2. Device Name

Proprietary name: OSTEON II Common name: . Bone grafting material Classification name: Bone grafting material, Synthetic

### 3. Predicated Device

K062834 OSTEON

#### 4. Description

This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.2~2.0 mm. It is supplied sterile by gamma irradiation.

#### 510(k) Summary

Page 1 of 3

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# ભાગમાં આવેલા ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના

### 5. Indication for use

OSTEON II 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 II has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of OSTEON II, OSTEON are as following

| | Material | Device name | |
|---|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Hydroxyapatite(HA) | OSTEON | OSTEON II |
| 2 | Beta-tricalciumphosphate(β-TCP) | 55~75wt% | 25~45wt% |
| | Particles of size | 25~45wt% | 55~75wt% |
| | | 0.3~2.0 mm | 0.2~2.0mm |
| | Indication for use | OSTEON (II) is intended for use as a bone grafting<br>material to fill, augment or reconstruct periodontal or<br>oral/maxillofacial defects.<br>- Periodontal/Infrabony defects<br>- Ridge augmentation<br>- Extraction sites (implant preparation/placement)<br>- Sinus lifts<br>- Cystic cavities | OSTEON (II) is intended for use as a bone grafting<br>material to fill, augment or reconstruct periodontal or<br>oral/maxillofacial defects.<br>- Periodontal/Infrabony defects<br>- Ridge augmentation<br>- Extraction sites (implant preparation/placement)<br>- Sinus lifts<br>- Cystic cavities |
| | Sterilization | Gamma Irradiation | Gamma Irradiation |

510(k) Summary

Page 2 of 3

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# GENOSS

### 7. Performance Data

Biocompatibility testing on the proposed OSTEON II 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 Pyrogencity -ISO Intracutaneous reactivity -ISO Ames

-ISO Systemic toxicity -ISO Sensitization · . -ISO Implantation -ISO Micro-nucleus

The proposed OSTEON II was evaluated using the following performance bench testing to confirm the performance characteristics:

| -Ca/P ratio | -Crystalline Phase Compositions |
|-------------|---------------------------------|
| -Porosity | -Water Solubility Test |
| -Density | -Crystallinity Value |

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON II met the established specifications necessary for consistent performance according to its intended use.

#### 7. Conclusion

Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that OSTEON II is substantially equivalent to predicate devices

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Mr. Sungwon Lee Quality Assurance Assistant Manager Genoss Company, Limited 1F Gyeonggi R&DB Center 906-5 Iui-Dong Suwon-Si, Yeongtong-Gu, Gyeonggi-Do Republic of Korea 443-270

JAN 1 7 2012

Re: K112716

Trade/Device Name: OSTEON II Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: January 4, 2012 Received: January 5, 2012

Dear Mr. 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.

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## Page 2 - Mr. Lee

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/CDRHQffices /ucm 115809.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.goy/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh 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

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## CEMOZZ

## Indication for use

| | 510(k) Number: |
|--|----------------|
|--|----------------|

Device Name: OSTEON II

Indication for use:

OSTEON II 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

イ Prescription Use __ (Part 21 CFR 801 Subpart D)

Indication for use

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)

Wh

(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K112716