(101 days)
Not Found
No
The device description and intended use focus on the material composition and physical properties of a ceramic bone void filler. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to fill and/or augment bony tissue and is replaced by host bone, indicating a therapeutic purpose in aiding the healing process.
No
The device is a bone void filler intended for surgical repair and augmentation of dental/oral/maxillofacial bony tissue, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is made of "medical grade combination of hydroxyapatite and b-tricalcium phosphate" and is a "porous implant," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body to provide information about a patient's health.
- Device Description and Intended Use: The description clearly states that MASTERGRAFT® Resorbable Ceramic Granules is a "bone void filler" and an "osteoconductive porous implant" that is "packed into bony voids or gaps" within the body. It is used to augment or reconstruct bone tissue.
- Lack of Diagnostic Function: The device's purpose is to physically fill and support bone regeneration within the body, not to analyze samples or provide diagnostic information.
Therefore, MASTERGRAFT® Resorbable Ceramic Granules is a medical device used for surgical implantation and bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MASTERGRAFT® Resorbable Ceramic Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Resorbable Ceramic Granules is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Procedures specific to MASTERGRAFT® Granules include:
- . Filling of dental extraction sockets
- Filling of cystic defects
- . Oral/maxillofacial auqmentation or reconstruction.
Procedures specific to MASTERGRAFT® Mini Granules include:
- Filling of periodontal defects .
- . Sinus lifts
- . Alveolar ridge augmentation
- . Filling of dental extraction sockets
- . Filling of cystic defects
- . Oral/maxillofacial augmentation or reconstruction.
MASTERGRAFT® Resorbable Ceramic Granules may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.
Product codes
NUN, LYC
Device Description
MASTERGRAFT® Resorbable Ceramic Granules is made of medical grade combination of hydroxyapatite and b-tricalcium phosphate. MASTERGRAFT® is provided in a 60 percent hydroxyapatite and 40 percent b-tricalcium phosphate formulation. Alternatively, MASTERGRAFT® may be provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MASTERGRAFT® Resorbable Ceramic Granules is an osteoconductive porous implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental oral/maxillofacial bony tissue
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
Not Found
Key Metrics
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.
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Medtronic Sofamor Danek MASTERGRAFT® Resorbable Ceramic Granules 510(K) Summary September 2008
Company:
Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Contact: Ryan Massev Regulatory Affairs Specialist
Classification Name:
Product Code:
Requlation No .:
MASTERGRAFT Resorbable Ceramic Granules Bone grafting material NUN 872.3930
JAN - 9 2009
. Product Description/Purpose of Application
II.Proposed Proprietary Trade Name:
MASTERGRAFT® Resorbable Ceramic Granules is made of medical grade combination of hydroxyapatite and b-tricalcium phosphate. MASTERGRAFT® is provided in a 60 percent hydroxyapatite and 40 percent b-tricalcium phosphate formulation. Alternatively, MASTERGRAFT® may be provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MASTERGRAFT® Resorbable Ceramic Granules is an osteoconductive porous implant.
The purpose of this 510(k) application is to expand the indications for the MASTERGRAFT® Resorbable Ceramic Granules device so that it may be used in the oral and maxillofacial region. Like the previously cleared predicates, MASTERGRAFT® Resorbable Ceramic Granules (K020986. SE 07/22/2002) and MBCP™ (K051885, SE 09/16/2005), the subject system is intended to be used alone or combined with autograft as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony
1 72
1
structure. In addition, MASTERGRAFT® Resorbable Ceramic Granules can
be mixed with autograft and used as a bone graft extender.
IV. Indications
MASTERGRAFT® Resorbable Ceramic Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Resorbable Ceramic Granules is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include;
- Filling of periodontal defects ●
- Filling of dental extraction sockets
- Filling of cystic defects
- Sinus lifts
- Alveolar ridge augmentation
- Oral/maxillofacial augmentation or reconstruction. .
MASTERGRAFT® Resorbable Ceramic Granules may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.
V. Substantial Equivalence
Documentation is provided that demonstrates MASTERGRAFT® Resorbable
Ceramic Granules to be substantially equivalent to the previously cleared
MASTERGRAFT® Resorbable Ceramic Granules (K020986, SE 07/22/2002) and MBCP™ (K051885, SE 09/16/2005).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
FEB 26 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr.Ryan Massey Regulatory Affairs Specialist Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132
Re: K082917/A001
Trade/Device Name: Mastercraft Resorbable Ceramic Granules Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: II Product Code: LYC Dated: January 27, 2009 Received: January 28, 2009
Dear Mr. Massey:
This letter corrects our substantially equivalent letter of January 9, 2009.
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 (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.
3
Page 2 - Mr. Massey
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 (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.
This letter will allow you to continue 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-Jsee OC organization structure below for correct phone extension]. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Suite H. Michie MD.
Ginette Y. Michaud, M. D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K082917
Device Name: MASTERGRAFT® Resorbable Ceramic Granules
Indications for Use:
MASTERGRAFT® Resorbable Ceramic Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Resorbable Ceramic Granules is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Procedures specific to MASTERGRAFT® Granules include:
- . Filling of dental extraction sockets
- Filling of cystic defects
- . Oral/maxillofacial auqmentation or reconstruction.
Procedures specific to MASTERGRAFT® Mini Granules include:
- Filling of periodontal defects .
- . Sinus lifts
- . Alveolar ridge augmentation
- . Filling of dental extraction sockets
- . Filling of cystic defects
- . Oral/maxillofacial augmentation or reconstruction.
MASTERGRAFT® Resorbable Ceramic Granules may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| Per 21 CFR 801.109 |
Robert J. Betz DDS for Dr. Susan Renner
(Division Sign-Off)
11 Division of Anesthesiclogy, General Hospital Infection Control, Lental Dental Devices
510(k) Number: K082917