(215 days)
Not Found
No
The 510(k) summary describes a synthetic bone graft material and does not mention any software, algorithms, or AI/ML capabilities.
Yes
OSTEON facilitates bone regeneration and reconstruction, which directly addresses a health condition (bone defects). The device is used for therapeutic purposes, rather than diagnostic or other non-therapeutic uses.
No
The device description clearly states "OSTEON is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects." Its purpose is to facilitate bone growth and repair, not to diagnose a condition.
No
The device description clearly states that OSTEON is a synthetic resorbable osteoconductive bone graft substitute composed of physical materials (beta-Tricalcium Phosphate and Hydroxyapatite) and is supplied as irregular shaped powders. This indicates it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that OSTEON is a bone grafting material used to fill, augment, or reconstruct defects in the body (periodontal or oral/maxillofacial). This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details the composition and physical form of the material, consistent with a bone graft substitute.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) to provide information about a patient's health status, which is the core function of an IVD.
- No Mention of Diagnostic Output: The device doesn't produce any diagnostic results or measurements.
IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. OSTEON is a material implanted into the body for structural support and regeneration.
N/A
Intended Use / Indications 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
Product codes
LYC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Periodontal, oral/maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
Date: 13 September 2006
APR 2 4 2007
-
- 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 |
-
- Device :
Proprietary Name - OSTEON Common Name - Bone Grafting Material Classification Name - Bone Grafting Material, Synthetic
- Device :
-
- Predicate Device : MBCPTM, Biomatlante, K051885
4. Description :
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.
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.
1
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.
2
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
3
GENOSS Co., Ltd.
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