MASTERGRAFT MATRIX

K023553 · Medtronic Sofamor Danek, Inc. · MQV · Apr 22, 2003 · Orthopedic

Device Facts

• Record ID: K023553
• Device Name: MASTERGRAFT MATRIX
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Apr 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MasterGraft™ Matrix combined with autogenous bone marrow is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Matrix is to be gently packed into bony voids or gaps 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™ Matrix provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

MasterGraft™ Matrix is a 3-dimensional, porous, osteoconductive bone void filler. It consists of a combination of purified bovine Type I collagen and a ceramic component (15% hydroxyapatite, 85% B-tricalcium phosphate). Supplied as a sterile, premixed strip for single-patient use. Intended for surgical implantation by packing into non-structural bony voids or gaps. The device acts as a scaffold for bony ingrowth, resorbing over time as it is replaced by natural bone during the healing process.

Technological Characteristics

Medical grade purified bovine Type I collagen; ceramic component (15% hydroxyapatite, 85% B-tricalcium phosphate); porous, 3-dimensional strip form; sterile; bioresorbable.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (spine, pelvis, ilium, extremities) not intrinsic to structural stability. Used in conjunction with autogenous bone marrow for surgically created or traumatic osseous defects.

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

• Master Graft™ Resorbable Ceramic (K020986)
• Master Graft™ Resorbable Ceramic (K012506)

Submission Summary (Full Text)

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# Medtronic Sofamor Danek MasterGraft™ Matrix 510(K) Summary (K023553) April 2003

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

### II. Proposed Proprietary Trade Name: MasterGraft™ Matrix

### III. Product Description

MasterGraft™ Matrix is made of medical grade combination of purified collagen and hydroxyapatite and B-tricalcium phosphate ceramic. The collagen is a highly purified bioresorbable lyophilized bovine tendon that is primarily Type I collagen. The ceramic portion of MasterGraft™ Matrix is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation. The product is supplied sterile in a premixed strip form for single patient use. MasterGraft™ Matrix is a 3-dimensional, 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.

#### IV. Indications

MasterGraff™ Matrix combined with autogenous bone manow is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Matrix is to be gently packed into bony voids or gaps 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™ Matrix provides a bone void filler that resorbs and is replaced with bone during the healing process.

#### V. Substantial Equivalence

Documentation was provided which demonstrated MasterGraft™ Matrix to be substantially equivalent to the previously cleared Master Graft™ Resorbable Ccramic (K020986 and K012506).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2003

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 31832

Re: K023553

Trade/Device Name: MasterGraft™ Matrix Regulatory Class: Unclassified Product Code: MQV Dated: February 11, 2003 Received: February 12, 2003

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. Iisting 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 - 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), please contact the Office of Compliance at (301) 594- . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A Millman

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): K023553

MasterGraft™ Matrix Device Name:

Indications for Use:

MasterGraft™ Matrix combined with autogenous bone marrow is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Matrix is to be gently packed into bony voids or gaps 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. MasterGraff™ Matrix 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
(F'er 21 CFR 801.109)
(Optional 1-2-96)
OR
Over-the-counter Use