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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called OSTEON III. It describes the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence, but it does not provide the details requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not contain any information about:

A table of acceptance criteria and reported device performance for clinical endpoints. It has a table comparing technological characteristics (composition, physical properties) to predicate devices, and lists biocompatibility and performance bench tests conducted, but not acceptance criteria for clinical outcomes.
Sample size used for a test set or data provenance for a clinical study. The document only references non-clinical testing.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Standalone (algorithm only) performance. (This device is a bone grafting material, not a software algorithm).
Type of ground truth used for a clinical study.
Sample size for a training set. (Again, this relates to an algorithm, which OSTEON III is not).
How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

Intended Use and Indications for Use: OSTEON III is for bone grafting to fill, augment, or reconstruct periodontal or oral/maxillofacial defects, similar to its predicates.
Technological Characteristics: Comparison of main materials (HA and β-TCP), device design (interconnected porous structure), composition, and physical properties (porosity, pore size, particle size, Ca/P ratio, crystallinity).
Biocompatibility Testing: A list of ISO 10993 tests performed (Cytotoxicity, Sensitization, Pyrogenicity, Intracutaneous reactivity, Systemic toxicity, Subchronic toxicity, Genotoxicity-Ames, Genotoxicity-Micro nucleus, Implantation, Genotoxicity-Chromosomal aberration, Endotoxin (LAL)). The results are stated as showing the materials are non-toxic and non-sensitizing.
Performance Bench Testing: A list of engineering tests like 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. The document states "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."

In summary, the provided document is a 510(k) summary for a bone grafting material, not a clinical study report for an AI/software device. Therefore, it does not contain the information requested in your prompt regarding clinical acceptance criteria, study design, or expert consensus details.

Summary

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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

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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

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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)

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Image /page/3/Picture/0 description: The image shows the logo for GENOSS. The logo is in green and consists of the word "GENOSS" in a sans-serif font. The letters "GEN" are in a darker green, while the letters "OSS" are in a lighter, lime green color. The logo has a modern and clean design.

K153676 510(k) Summary

1. Company

	Submitter
Name	GENOSS Co., Ltd.
Address	1F Gyeonggi R&DB center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si,Gyeonggi-do, 433-270, Korea
Phone/Fax	+82-31-888-5100/ +82-31-888-5595
Contact person	Eunsang Lee / RAeslee@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

510(k) Summary

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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/Infrabony defects- Ridge augmentation-Extraction sites(implant preparation /placement)- Sinus lifts	- Osteogenic scaffoldfor bone healing- Promotesosteoblasticproliferation anddifferenciation.- Stimulates theosteoblastic response.	- Sinus lift- Bony defects of thealveolar ridge- Intraosseous defects- Peri-implant defects- Extraction sockets
Applicable	Human Oral, periodontal
Function	Osteoconductive
Device Design
Physical morphology	Interconnectingmacro and micro pores
Performance	Bone formation
Surgical site	Oral, Periodontal
Package	Glass vial,Glass syringe	Glass, Plastic vialGlass syringe	Glass, Plastic vial

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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 phasecomposition	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

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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

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
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.(b)
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.