MASTERGRAFT RESORBABLE CERAMIC GRANULES

K012506 · Medtronic Sofamor Danek USA, Inc. · MQV · Mar 7, 2002 · Orthopedic

Device Facts

• Record ID: K012506
• Device Name: MASTERGRAFT RESORBABLE CERAMIC GRANULES
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Mar 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, 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™ Bone Void Filler is an osteoconductive porous implant used to fill bony voids or gaps in the skeletal system. It consists of a combination of hydroxyapatite and ß-tricalcium phosphate, available in two formulations (60/40 or 15/85 ratio). The device is supplied sterile for single patient use. During surgical procedures, the filler is manually packed into osseous defects by a surgeon. The material acts as a scaffold that resorbs over time and is replaced by natural bone during the healing process. It is intended for non-load-bearing applications where the defect does not compromise the structural stability of the bone.

Clinical Evidence

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

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 for single patient use.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (spine, pelvis, extremities) where the void or gap is not intrinsic to the stability of the bony structure.

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.

Submission Summary (Full Text)

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# KOI2506

7 2002 MAR

### Medtronic Sofamor Danek MasterGraft™ Bone Void Filler 510(K) Summary March 2002

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

#### Proposed Proprietary Trade Name: MasterGraft™ Bone Void Filler II.

#### Product Description III.

MasterGraff™ Bone Void Filler is made of medical grade combination of hydroxyapatite and ßtricalcium phosphate. MasterGraft™ is provided in a 60 percent hydroxyapatite and 40 percent ßtricalcium 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™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraf™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

#### V. Substantial Equivalence

Documentation was provided which demonstrated the MasterGraft™ Bone Void Filler to be substantially equivalent to other previously cleared bone void fillers.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2002 MAR

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

Re: K012506

MasterGraft™ Bone Void Filler Regulatory Class: unclassified Product Code: MQV Dated: December 5, 2001 Received: December 7, 2001

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 (QS) regulation (21 CFR Part 820); and if

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

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 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 N Milbersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

for Mark N Millerson

al, Restorative

510(k) Number

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510(k) Number (if known):

MasterGraft Bone Void Filler Device Name:

### Indications for Use:

MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, 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<br>(Per 21 CFR 801.109)<br>(Optional 1-2-96) | |
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OR

| Over-the-counter Use | ____________________ |
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for Mark A. Mellema
Division Sign-Off

, Restorative and Neurologica

510(k) Number K012506