MASTERGRAFT RESORBABLE CERAMIC

K020986 · Medtronic Sofamor Danek, Inc. · MQV · Jul 22, 2002 · Orthopedic

Device Facts

• Record ID: K020986
• Device Name: MASTERGRAFT RESORBABLE CERAMIC
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Jul 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MasterGraft™ Resorbable Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Resorbable Ceramic is to be gently packed into bony voids of the skeletal system (e.g., the 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.

Device Story

MasterGraft™ Resorbable Ceramic is an osteoconductive porous bone void filler. It consists of a medical-grade combination of hydroxyapatite and ß-tricalcium phosphate, available in two formulations (60/40 or 15/85). The device is supplied sterile for single-patient use. It is intended to be packed into non-structural bony voids or gaps resulting from surgery or trauma. Once implanted, the material resorbs and is replaced by natural bone during the healing process. The device is used by surgeons in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Osteoconductive porous implant composed of hydroxyapatite and ß-tricalcium phosphate. Formulations: 60% hydroxyapatite/40% ß-tricalcium phosphate or 15% hydroxyapatite/85% ß-tricalcium phosphate. Supplied sterile.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (spine, pelvis, ilium, extremities) not intrinsic to bony stability. Defects may be surgically created or traumatic in origin.

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

• Interpore Cross International ProOsteon 500R (K990131)

Submission Summary (Full Text)

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# JUL 2 2 2002

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## Medtronic Sofamor Danek MasterGraft™ Resorbable Ceramic 510(K) Summary - K020986 May 2002

- Medtronic Sofamor Danek USA I. Company: 1800 Pvramid Place Memphis. TN 38132 [phone]
#### Proposed Proprietary Trade Name: MasterGraft™ Resorbable Ceramic II.

#### III. Product Description

MasterGraft™ Resorbable Ceramic is made of medical grade combination of hydroxyapatite and ß-tricalcium phosphate. MasterGraft™ is provided in a 60 percent hydroxyapatite and 40 percent ß-tricalcium phosphate formulation. Alternatively, MasterGraft™ may be provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MasterGraft™ is an osteoconductive porous implant.

#### IV. Indications

MasterGraft™ Resorbable Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Resorbable Ceramic is to be gently packed into bony voids of the skeletal system (e.g., the 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.

#### V. Purpose of the Submission

The purpose of this submission was to increase the granule size of the MasterGraft™ device and to expand the indications to include the ilium.

#### VI. Substantial Equivalence

Documentation was provided which demonstrated the MasterGraft™ Resorbable Ceramic to be substantially equivalent to itself and Interpore Cross International ProOsteon 500R (K990131).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 2 2002

Richard W. Treharne, Ph.D. Senior Vice President Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K020986

Trade/Device Name: MasterGraft™ Resorbable Ceramic Regulatory Class: Unclassified Product Code: MQV Dated: May 3, 2002 Received: May 7, 2002

Dear Dr. Treharne:

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.

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.

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Page 2 - Richard W. Treharne, Ph.D.,

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Mark A. Melberon

Celia M. Witten, Ph.D., M.D. 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): K020986

Device Name:__________________________________________________________________________________________________________________________________________________________________ MasterGraft™ Resorbable Ceramic

### Indications for Use:

MasterGraft™ Resorbable Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraff™ Resorbable Ceramic is to be gently packed into bony voids of the skeletal system (e.g., the 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.

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### Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

OR

Over-the-counter Use __

for Mark A. Millman

General, Restorative and Neurological Devices

510(k) Number _

000031