MASTERGRAFT PUTTY

K140374 · Medtronic Sofamor Danek USA, Inc. · LYC · Jun 10, 2014 · Dental

Device Facts

• Record ID: K140374
• Device Name: MASTERGRAFT PUTTY
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: LYC · Dental
• Decision Date: Jun 10, 2014
• 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; composed of purified Type I bovine collagen and biphasic calcium phosphate ceramic (15% hydroxyapatite, 85% ß-tricalcium phosphate). Supplied as a dry, solid construct; hydrated by clinician with sterile water or autograft before use. Implanted into bony voids or gaps in oral/maxillofacial sites by surgeons. Functions as a scaffold for bony ingrowth; resorbs at a rate consistent with natural bone healing. Used with or without internal fixation; serves as bone graft extender when mixed with autograft. Benefits patient by facilitating bone repair in dental/maxillofacial defects.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical testing, including a two-month rabbit bilateral posterolateral spine fusion study and a four-month sheep study evaluating bony healing and repair.

Technological Characteristics

Material: Type I bovine collagen and biphasic calcium phosphate ceramic (15% hydroxyapatite, 85% ß-tricalcium phosphate). Form: Sterile, dry, moldable, porous implant. Mechanism: Osteoconductive scaffold. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring bone void filling or augmentation in dental/oral/maxillofacial bony tissue, including surgically created osseous defects or traumatic bone injuries. Procedures include periodontal defect filling, dental extraction socket filling, cystic defect filling, sinus lifts, alveolar ridge augmentation, and oral/maxillofacial reconstruction.

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 (K081784)

Reference Devices

• MASTERGRAFT® Putty (K071813)
• MASTERGRAFT® Putty (K051386)

Submission Summary (Full Text)

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# JUN 1 0 2014

# 510(K) Summary

## K140374

| I. SUBMITTER NAME & ADDRESSS: | Medtronic Sofamor Danek USA, Inc<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone]<br>Establishment Registration: 1030489 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Kelly Anglin<br>Senior Regulatory Affairs Specialist |
| DATE PREPARED: | May 13, 2014 |

II. PROPOSED PROPRIETARY TRADE NAME: MASTERGRAFT® Putty

| DEVICE CLASSIFICATION NAME: | Bone grafting material, synthetic<br>Bone grafting material, animal source |
|------------------------------|----------------------------------------------------------------------------|
| REGULATION NUMBER: | 21 CFR 872.3930 |
| CLASSIFICATION PRODUCT CODE: | LYC, NPM |
| CLASS: | II |

### III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:

| Table 1. Legally Marketed Devices | | |
|-----------------------------------|---------------|------------------------------|
| Device name | 510(k) number | Substantial Equivalence date |
| MASTERGRAFT® Putty | K081784 | 09/17/2008 |

## IV. DEVICE DESCRIPTION:

MASTERGRAFT® Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the MASTERGRAFT® Putty device is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß

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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. MASTERGRAFT® Putty is a 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 Changes Being Effected 510(k) application is to notify FDA of the additional contraindication in the Instructions for Use (IFU).

#### V. 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:

- o Filling of periodontal defects
- Filling of dental extraction sockets o
- Filling of cystic defects o
- o Sinus lifts
- o Alveolar ridge augmentation
- O Oral/maxillofacial augmentation or reconstruction.

MASTERGRAFT® Putty may be used with or without internal fixation, and maybe mixed with autograft as a bone graft extender.

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| Table 2. Summary of the technological Characteristics | | |
|-------------------------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------|
| Comparison Feature | Subject MASTERGRAFT®<br>Putty | Predicate MASTERGRAFT®<br>Putty K081784 (S.E.09/17/2008) |
| Indication for Use | Identical | K081784 (S.E. 09/17/2008) |
| Fundamental Scientific<br>Technology<br>• Operating Principle<br>• Mechanism of<br>Action | Identical | K081784 (S.E. 09/17/2008) |
| Basic Design | Identical | K081784 (S.E. 09/17/2008) |
| Performance | Identical | K081784 (S.E. 09/17/2008) |
| Sterilization | Identical | K081784 (S.E. 09/17/2008) |
| Shelf-Life | Identical | K081784 (S.E. 09/17/2008) |
| Packaging | Identical | K081784 (S.E. 09/17/2008) |
| Use of rigid fixation | Identical | K081784 (S.E. 09/17/2008) |
| Safety and Effectiveness<br>profile | Identical | K081784 (S.E. 09/17/2008) |

## VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:

#### VII. DISCUSSION OF NON-CLINICAL TESTING:

Non-clinical testing was performed in accordance with FDA Recognized Consensus Standards and FDA Quidelines, where applicable. Two animal studies were performed: a two-month rabbit bilateral posterolateral spine fusion to assess MASTERGRAFT® Putty (K071813 S.E. 11/09/07, K051386 S.E. 12/16/2005) as a suitable bone graft extender and a four-month sheep study evaluating the ability of MASTERGRAFT® Putty to effect bony healing and repair.

### VIII. CONCLUSION:

Documentation provided in this submission demonstrates that the subject device is substantially equivalent to the previously cleared MASTERGRAFT® Putty device K081784 (S.E. 09/17/2008). The subject device is substantially equivalent to predicate MASTERGRAFT® Putty in several categories including: indication, material components, sterility, shelf-life, and biocompatibility.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 10, 2014

Medtronic Sofamor Danek USA, Incorporated Ms. Kelly Anglin Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, TN 38132

Re: K140374

Trade/Device Name: MASTERGRAFT® Putty Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material, synthetic Bone grafting material, animal source

Regulatory Class: II Product Code: LYC, NPM Dated: May 13, 2014 Received: May 15, 2014

Dear Ms. Anglin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Ms. Anglin

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 Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MarySTBurmer-S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K140374 510(k) Number (if known):

Device Name: MASTERGRAFT® Putty

#### 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 (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ (21 CFR Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Gree 2014.06.10 12.

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