(278 days)
Not Found
No
The summary describes a synthetic bone graft material and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, which constitutes a therapeutic intervention to treat a medical condition.
No
This device is a material indicated for filling and/or augmenting osseous defects, which means it is used for treatment rather than diagnosis.
No
The device description clearly states it is a physical, resorbable, synthetic copolymer material in powder, putty, or gel form, intended for filling bone defects. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for filling and/or augmenting osseous defects within the body (intraoral/maxillofacial). This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The device is a synthetic material designed to integrate with bone tissue. It's a physical implant/filler, not something used to test samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
ReOss Granules TM are indicated for filling and/or augmenting ReOss intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation graffing.
ReOss" Powder, Putty and Gel are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
Product codes
MQV, LYC
Device Description
ReOss™ is a hydrophilic, highly porous, resorbable, synthetic copolymer permeated with osteoconductive sub-micron particles of Hydroxyapatite. It is configured as a multi-pore, three-dimensional scaffold that is engineered to integrate with the physiochemical state of bone tissue.
ReOss™ is available as a Powder, Putty or Reverse Phase Injectable Gel.
Products are provided in sterile packaging in various dosage volumes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral/maxillofacial osseous defects, intrabony periodontal osseous defects, furcation defects, bony defects of the alveolar ridge, tooth extraction sites, sinus
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)
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Intra-Lock International has provided information to demonstrate conformity with FDA's quidance document entitled Bone Grafting Materials, 872.3930 and Resorbable calcium salt bone void filler device 888.3045. In addition, theses guidance documents were also consulted during our preparation of this application for permission to market these products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071237, K040514, K042706, K080308, K060061, K053098, K071206, K040419
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
510(k) Summary
Establishment:
Intra-Lock International, Inc. 6560 West Rogers Circle Suite 24 Boca Raton, FL 33487
MAY 27 2009
Proprietary Name: ReOss™ Products
Classification Name: Bone Grafting Materials, 872.3930 Resorbable calcium salt bone void filler device 888.3045
Device Classification: Class Il
Predicate Devices:
| Granular | Manufacturer | Product
Code | K# |
|----------------------|----------------------------------------|-----------------|---------|
| Copios BVF | Kensy Nash/Zimmer | MQV | K071237 |
| Eovia | Orthotec | MQV | K040514 |
| OsSatura | Isotis | LYC | K042706 |
| Bioscaff Alvelac | Bio-Scaffold
International Pte Ltd. | LYC | K080308 |
| Putty | Manufacturer | Product
Code | K# |
| Stryker TCP | Stryker | MQV | K060061 |
| Optimum DBM | LifeNet | MQV | K053098 |
| Actifuse ABX E-Z fil | Apatec | MQV | K071206 |
| Dynagraft | Isotis | MQV | K040419 |
| Putty | Manufacturer | Product
Code | K# |
| Optimum DBM | LifeNet | MQV | K053098 |
| DynaGraft | Isotis | MQV | K040419 |
1
K0802419
Material Description:
ReOss™ is a hydrophilic, highly porous, resorbable, synthetic copolymer permeated with osteoconductive sub-micron particles of Hydroxyapatite. It is configured as a multi-pore, three-dimensional scaffold that is engineered to integrate with the physiochemical state of bone tissue.
ReOss™ is available as a Powder, Putty or Reverse Phase Injectable Gel.
Products are provided in sterile packaging in various dosage volumes. ReOss
Intended Use:
Dental Applications
TM are indicated for filling and/or augmenting ReOss Granules intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation graffing.
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Intra-Lock International has provided information to demonstrate conformity with FDA's quidance document entitled Bone Grafting Materials, 872.3930 and Resorbable calcium salt bone void filler device 888.3045. In addition, theses guidance documents were also consulted during our preparation of this application for permission to market these products.
2
Conclusion:
Based on the indications for use, technological characteristics, and
comparison to predicate devices, the Intra-Lock ReOss" products have been shown to be safe and effective for its intended use.
3
Image /page/3/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
MAY 27 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffery Sakoff Vice President, Director of Operations Intra-Lock International, Incorporated 6560 West Rogers Circle, Suite 24 Boca Raton, Florida 33487
Re: K082419
Trade/Device Name: ReOss Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: MQV, LYC Dated: May 12, 2009 Received: May12, 2009
Dear Mr. Sakoff:
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 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.
4
Page 2- Mr. Sakoff
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runner
Susan Runner, D.D.S., M.A.
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K082419
Device Name: ReOss
Indications For Use:
ReOss" Powder, Putty and Gel are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulvey for MSN
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices .
KO8241 510(k) Number: