MASTERGRAFT RESORBABLE CERAMIC GRANULES

K082917 · Medtronic Sofamor Danek · LYC · Jan 9, 2009 · Dental

Device Facts

• Record ID: K082917
• Device Name: MASTERGRAFT RESORBABLE CERAMIC GRANULES
• Applicant: Medtronic Sofamor Danek
• Product Code: LYC · Dental
• Decision Date: Jan 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 augmentation 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.

Device Story

MASTERGRAFT® Resorbable Ceramic Granules are osteoconductive porous implants used as bone void fillers or graft extenders in oral and maxillofacial surgery. The device consists of a combination of hydroxyapatite and beta-tricalcium phosphate. It is packed into bony voids or gaps by a surgeon to facilitate remodeling and replacement by host bone during the healing process. The granules may be used with or without internal fixation and can be mixed with autograft. The device is supplied sterile for single-patient use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Osteoconductive porous implant composed of hydroxyapatite and beta-tricalcium phosphate. Available in two formulations: 60% hydroxyapatite/40% beta-tricalcium phosphate or 15% hydroxyapatite/85% beta-tricalcium phosphate. Supplied sterile for single-patient use.

Indications for Use

Indicated for patients requiring bone void filling or augmentation in dental and oral/maxillofacial regions. Used for surgically created or traumatic osseous defects, including periodontal defects, extraction sockets, cystic defects, sinus lifts, and alveolar ridge augmentation. Can be used alone or with autograft.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MASTERGRAFT® Resorbable Ceramic Granules (K020986)
• MBCP™ (K051885)

Submission Summary (Full Text)

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K082917

io72

Medtronic Sofamor Danek MASTERGRAFT® Resorbable Ceramic Granules 510(K) Summary September 2008

Company:

-

Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 Telephone: [phone] Fax: [phone]

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

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K082917

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).

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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.

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### 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 [phone] or [phone] 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