MASTERGRAFT RESORBABLE CERAMIC GRANULES

K082918 · Medtronic Sofamor Danek · MQV · Feb 9, 2009 · Orthopedic

Device Facts

• Record ID: K082918
• Device Name: MASTERGRAFT RESORBABLE CERAMIC GRANULES
• Applicant: Medtronic Sofamor Danek
• Product Code: MQV · Orthopedic
• Decision Date: Feb 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MASTERGRAFT® Resorbable Ceramic Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT® Resorbable Ceramic Granules can be used with autograft as a bone graft extender. MASTERGRAFT® Resorbable Ceramic Granules is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ilium and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® Resorbable Ceramic Granules provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

MASTERGRAFT® Resorbable Ceramic Granules is an osteoconductive, porous bone void filler composed of hydroxyapatite and b-tricalcium phosphate. Supplied sterile for single-patient use, it is designed to be packed into non-structural bony voids or gaps in the skeletal system. The device acts as a scaffold that resorbs over time, facilitating replacement with natural bone during the healing process. It is intended for use by surgeons in clinical settings to treat osseous defects resulting from surgery or trauma. The device can be used alone or mixed with autograft to serve as a bone graft extender, aiding in bone repair and regeneration.

Clinical Evidence

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

Technological Characteristics

Porous ceramic granules composed of hydroxyapatite (60% or 15%) and b-tricalcium phosphate (40% or 85%). Osteoconductive material. Supplied sterile for single-patient use. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (e.g., posterolateral spine, pelvis, ilium, extremities) where bony voids or gaps are not intrinsic to structural stability. May be used alone or as a bone graft extender with autograft.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MASTERGRAFT® Resorbable Ceramic Granules (K020986)
• MBCP™ (K051774)

Submission Summary (Full Text)

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Koszylis

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

FEB - 9 2009

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

Contact: Rvan Massev Regulatory Affairs Specialist

II.Proposed Proprietary Trade Name:

Classification Name:

Product Code: Regulation No .:

l.

MASTERGRAFT Resorbable Ceramic Granules Resorbable calcium salt bone void filler MQV 888.3045

#### 111. Product Description/Purpose of Application

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 with autograft as a bone graft extender, as well as expand the size range to include smaller sizes. Like the previously cleared predicates, MASTERGRAFT® Resorbable Ceramic Granules (K020986, SE 07/22/2002) and MBCP™ (K051774, SE 01/20/2006), the subject system is intended as a bone void filler for bony voids or gaps that are not intrinsic to the stability

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of the bony 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 is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT® Resorbable Ceramic Granules can be used with autograft as a bone graft extender. MASTERGRAFT® Resorbable Ceramic Granules is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ilium and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® Resorbable Ceramic Granules provides a bone void filler that resorbs and is replaced with bone during the healing process.

#### 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™ (K051774, SE 01/20/2006).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek USA, Inc. % Mr. Ryan Massey Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

FEB - 9 2009

Re: K082918

Trade/Device Name: MASTERGRAFT® Resorbable Ceramic Granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: January 22, 2009 Received: February 3, 2009

Dear Mr. Massey:

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. Ilsting 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.

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.

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### Page 2 - Mr. Ryan Massey

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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known):

Device Name: MASTERGRAFT® Resorbable Ceramic Granules

## Indications for Use:

MASTERGRAFT® Resorbable Ceramic Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT® Resorbable Ceramic Granules can be used with autograff as a bone graft extender. MASTERGRAFT® Resorbable Ceramic Granules is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ilium and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® provides a bone void filler that resorbs and is replaced with bone during the healing process.

Prescription Use Per 21 CFR 801.109

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Over-The-Counter Use


(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_ Cb)2-