OSTEON is a synthetic resorbable osteoconductive bone graft substitute composed of beta-Tricalcium Phosphate (B -TCP). Hydroxyapatite(HA) and OSTEON presents ત્વ interconnected porosity structure, similar to that of human cancellous bone. OSTEON is available as irregular shaped powders of size 0.3~2.0 mm. It is supplied sterile.

AI/ML Overview

This 510(k) summary does not contain information typically found in a study demonstrating device performance against specific acceptance criteria. This document is a premarket notification for a bone grafting material (OSTEON) and focuses on establishing substantial equivalence to a predicate device (MBCP™).

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because these elements are not present.

The document primarily states:

Device Description: OSTEON is a synthetic resorbable osteoconductive bone graft substitute composed of beta-Tricalcium Phosphate (β-TCP) and Hydroxyapatite (HA).
Intended Use: As a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects (e.g., periodontal/infrabony defects, ridge augmentation, extraction sites, sinus lifts, cystic cavities).
Comparison to Predicate Device: OSTEON has similar technological characteristics (main material, indication for use, and design) to MBCPTM.
Safety and Performance: "OSTEON has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." (However, the specific results or criteria are not detailed).
Conclusion: "Based on the information provided in this premarket notification GENOSS Co., Ltd. concludes that OSTEON is safe and effective and substantially equivalent to predicate devices as described herein."

For medical device clearances based on substantial equivalence, the primary "acceptance criteria" is typically demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantitative performance metrics against a defined gold standard in a clinical study presented within the 510(k) summary itself. The burden of proof primarily lies in showing similar technological characteristics and indications for use, supported by general safety (e.g., biocompatibility) and performance data, not necessarily complex multi-reader studies or detailed performance metrics.

Summary

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510(k) Summary

Date: 13 September 2006

APR 2 4 2007

1. Company making the submission:

	Submitter
Name	GENOSS Co., Ltd.
Address	27-5lui-dong Yeongtong-gu Suwon-si Gyeonggi-do,Republic of Korea 443-270
Phone	+82-31 207-2200
Fax	+82-31 207-3315
Contact	Keith Jung / manager
Internet	ikjung@implantium.com

1. Device :
  Proprietary Name - OSTEON Common Name - Bone Grafting Material Classification Name - Bone Grafting Material, Synthetic
1. Predicate Device : MBCPTM, Biomatlante, K051885

4. Description :

5. Indication for use :

OSTEON 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. Review :

OSTEON Implant System has the similar technological characteristics as the predicate device; main material, Indication for use and design.

OSTEON has been subjected to extensive safety, performance, and product validations prior to Safety tests including biocompatibility have been performed to ensure the devices release. comply with the applicable International and US regulations.

7. Conclusions :

Based on the information provided in this premarket notification GENOSS Co., Ltd. concludes that OSTEON is safe and effective and substantially equivalent to predicate devices as described herein.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genoss Company, Limited C/O Mr. Klass Besseling Consultant Spherelink, LLC 28711 Jaeger Drive Laguna Niguel, California 92677

APR 2 4 2007

Re: K062834 Trade/Device Name: OSTEON Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: April 5, 2007 Received: April 16, 2007

Dear Mr. Besseling:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Besseling

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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sipa Rame
Chiu Lin, Ph.D.

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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GENOSS Co., Ltd.

K062834

Indications for Use

510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

Device Name: OSTEON

OSTEON 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

Prescription Use_ (21CFR801 Subpart D) AND/OR

Over-The-Counter Use

(21CFR801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

General Hospital,
...ion Control, Sterile Devices
K) Number: K062534

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.