MASTERGRAFT PUTTY

K081784 · Medtronic Sofamor Danek · LYC · Sep 17, 2008 · Dental

Device Facts

• Record ID: K081784
• Device Name: MASTERGRAFT PUTTY
• Applicant: Medtronic Sofamor Danek
• Product Code: LYC · Dental
• Decision Date: Sep 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty 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® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

Device Story

MASTERGRAFT® Putty is a sterile, moldable, osteoconductive bone void filler. It consists of Type I bovine collagen and biphasic calcium phosphate ceramic (15% hydroxyapatite, 85% beta-tricalcium phosphate). The device is hydrated with sterile water or mixed with autograft before being packed into bony voids or gaps in the oral/maxillofacial region. It acts as a scaffold for bony ingrowth and is resorbed/remodeled by the body at a rate consistent with natural bone healing. It is intended for use by clinicians in surgical settings to treat osseous defects resulting from surgery or trauma.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Composition: Type I bovine collagen and biphasic calcium phosphate ceramic (15% hydroxyapatite, 85% beta-tricalcium phosphate). Form: Sterile, dry, solid construct, hydrated for use as a moldable putty. Mechanism: Osteoconductive, porous implant. Sterilization: Not specified.

Indications for Use

Indicated for filling or augmenting dental and oral/maxillofacial bony defects, including periodontal defects, extraction sockets, cystic defects, sinus lifts, and alveolar ridge augmentation. Applicable to surgically created or traumatic osseous defects in patients requiring bone void filling or augmentation.

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® Putty (K071813)
• MSD Biphasic Calcium Bone Void Filler (K010701)
• Calcium Hydroxylapatite Implant (K030682)
• Osteon (K062834)
• MBCP™ (K051885)

Submission Summary (Full Text)

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## Medtronic Sofamor Danek MASTERGRAFT® Putty 510(k) Summary June 2008

SEP 1 7 2008

- Medtronic Sofamor Danek USA l. Company: 1800 Pyramid Place Memphis, TN 38132 Telephone: [phone] Fax: [phone]
Contact: Michelle Obenauer Regulatory Affairs Manager

- Proposed Proprietary Trade Name: MASTERGRAFT® Putty ll. Classification Name: Bone Grafting Materials, Synthetic Product Code: LYC 872.3930 Regulation No .:
#### Product Description/Purpose of Application III.

MASTERGRAFT® Putty is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. The collagen component is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct that is hydrated for single patient use and is a moldable form of bone void filler. The device is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible. MASTERGRAFT® Putty has been shown to heal bone defects.

The purpose of this 510(k) application is to expand the indication for the MASTERGRAFT® Putty device to include use in the oral and oral/maxillofacial regions.

#### IV. Indications

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K08/784

MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty 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® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

#### Substantial Equivalence V.

Documentation was provided which demonstrated MASTERGRAFT® Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K071813), MSD Biphasic Calcium Bone Void Filler (K010701), Calcium Hydroxylapatite Implant (K030682), Osteon (K062834) and MBCP™ (K051885).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michelle Obenauer Regulatory Affairs Manager Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132

# SEP 1 7 2008

Re: K081784

Trade/Device Name: MASTERGRAFT® Putty Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: September 15, 2008 Received: September 15, 2008

Dear Ms. Obenauer:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

J.H. Samuels-Vendor BCH

Chiu S. Lin. Ph. D Division 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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K081784

510(k) Number (if known):

MASTERGRAFT® Putty Device Name:

### Indications for Use:

MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty 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® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

Prescription Use X

AND/OR

Over-The-Counter Use

1 881

(Part 21 CFR 801 Subpart D) C)

(21 CFR 807 Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rums

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081784