MASTERGRAFT PUTTY

K071813 · Medtronic Sofamor Danek · MQV · Nov 9, 2007 · Orthopedic

Device Facts

• Record ID: K071813
• Device Name: MASTERGRAFT PUTTY
• Applicant: Medtronic Sofamor Danek
• Product Code: MQV · Orthopedic
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Matrix is to be combined with autogenous bone marrow and is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices resorb and is replaced with bone during the healing process.

Device Story

MASTERGRAFT® Putty is an osteoconductive, porous bone void filler; composed of Type 1 bovine collagen, 15% hydroxyapatite, and 85% ß-tricalcium phosphate. Clinician mixes putty with autogenous bone marrow, sterile water, or autograft to create a moldable implant. Device is packed into non-structural bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) to facilitate bony ingrowth. Implant resorbs at a rate consistent with natural bone healing, eventually being replaced by host bone. Used by surgeons in clinical settings to treat surgically created or traumatic osseous defects.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Porous, osteoconductive implant; composition: Type 1 bovine collagen, 15% hydroxyapatite, 85% ß-tricalcium phosphate. Supplied sterile for single-patient use. Moldable consistency when hydrated with autogenous bone marrow, sterile water, or autograft.

Indications for Use

Indicated for patients requiring bone void filling or bone graft extension in the skeletal system (posterolateral spine, pelvis, ileum, extremities). Applicable to surgically created osseous defects or traumatic bone injuries. Not for use in defects intrinsic to bony structure stability.

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® Putty (K051386)
• MBCP™ (K051774)
• MASTERGRAFT® Matrix Resorbable Ceramic (K020986)
• MASTERGRAFT® Matrix Resorbable Ceramic (K012506)
• Vitoss Scaffold Foam Flow Bone Graft Material (K032288)
• HEALOS® Bone Graft Material (K043308)
• HEALOS® Bone Graft Material (K012751)

Submission Summary (Full Text)

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# Medtronic Sofamor Danek MASTERGRAFT® Putty 510(K) Summary June 2007

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

> Christine Scifert Contact: Director, Regulatory Affairs

- II. Proposed Proprietary Trade Name: MASTERGRAFT® Putty Classification Name: Bone Void Filler MQV Product Code: 888.3045 Regulation No .:
#### III. Product Description/Purpose of Application

MASTERGRAFT® Putty is made of medical grade combination of purified Type 1 bovine collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. When mixed with either autogenous bone marrow, and/or sterile water, and/or autograft the product forms into a putty, which is moldable. The product is supplied sterile for single patient use. MASTERGRAFT® Putty 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.

The purpose of this 510(k) application is to expand the indication for the MASTERGRAFT® Putty device so that it may be used with autograft as a bone graft extender.

#### IV. Indications

MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Matrix is to be combined with autogenous bone marrow and is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

NOV 0 9 2007

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Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices resorb and is replaced with bone during the healing process.

### V. Substantial Equivalence

Documentation was provided which demonstrated MASTERGRAFT®Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K051386), MBCP™ (K051774), MASTERGRAFT® Matrix Resorbable Ceramic (K020986 and K012506), and to Orthovita's Vitoss Scaffold Foam Flow Bone Graft Material (K032288) and DePuy's HEALOS® Bone Graft Material (K043308 and K012751).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is stylized and composed of thick, curved lines, giving it a modern and symbolic appearance. The text is in uppercase and evenly spaced to follow the circular shape of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Medtronic Sofamor Danek % Ms. Michelle Obenauer Regulatory Affairs Supervisor 1800 Pyramid Place Memphis, Tennessee 31832

K071813 Re:

Trade/Device Name: MASTERGRAFT® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV Dated: October 4, 2007 Received: October 9, 2007

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 for ass stated in the 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.

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 – Ms. Michelle Obenauer

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 (240) 276-276-0120. 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. Melkerson

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

Enclosure

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Ko71813 510(k) Number (if known):

MASTERGRAFT® Putty Device Name: --

### Indications for Use:

MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Matrix is to be combined with autogenous bone marrow and is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices resorb and is replaced with bone during the healing process.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K071813