MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP

K141824 · Medtronic Sofamor Danek, Inc. · MQV · Sep 5, 2014 · Orthopedic

Device Facts

• Record ID: K141824
• Device Name: MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Device Story

MASTERGRAFT® Matrix EXT is a sterile, porous, osteoconductive bone void filler; composed of purified bovine Type I collagen and biphasic calcium phosphate ceramic (15% hydroxyapatite, 85% beta-tricalcium phosphate). Supplied as a premixed strip for single-patient use; readily absorbs autogenous bone marrow aspirate. Implanted by surgeons into non-structural bony voids or gaps in the skeletal system (spine, pelvis, ilium, extremities). Device acts as a scaffold for bony ingrowth; resorbs over time as it is replaced by natural bone during the healing process. Intended to facilitate bone repair in surgically created or traumatic defects.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical testing previously performed for MASTERGRAFT® Strip (K082166) and MASTERGRAFT® UltraMatrix (K130335), conducted in accordance with FDA recognized consensus standards.

Technological Characteristics

Bioresorbable implant; material: >95% purified Type I bovine collagen and biphasic calcium phosphate ceramic (15% hydroxyapatite/85% beta-tricalcium phosphate). Form factor: premixed strip. Osteoconductive, porous structure. Sterilized for single-patient use. No electronic or software components.

Indications for Use

Indicated for patients requiring bone graft extension for bony voids or gaps not intrinsic to skeletal stability. Applicable to posterolateral spine, pelvis, ilium, and extremities. Defects may be surgically created or result from traumatic injury. Must be combined with autogenous bone marrow.

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® UltraMatrix (K130335)
• MASTERGRAFT® Strip (K140375)
• MASTERGRAFT® Putty (K140375)

Reference Devices

• MASTERGRAFT® Strip (K082166)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2014

Medtronic Sofamor Danek USA Inc. Ms. Courtney N. Long Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K141824

Trade/Device Name: MASTERGRAFT® Matrix EXT Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 1, 2014 Received: July 7, 2014

Dear Ms. Long:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Laurence D/ Coyne -A

For Mark N. Melkerson

Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K141824

Device Name MASTERGRAFT® Matrix EXT

#### Indications for Use (Describe)

MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| I. SUBMITTER NAME & ADDRESSS: | Medtronic Sofamor Danek USA, Inc<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone]<br>Establishment Registration: 1030489 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Courtney N. Long<br>Regulatory Affairs Specialist |
| DATE PREPARED: | July 1, 2014 |
| II. PROPOSED PROPRIETARY TRADE NAME: | MASTERGRAFT® Matrix EXT |
| DEVICE CLASSIFICATION NAME: | Resorbable Calcium Salt Bone Void<br>Filler |
| REGULATION NUMBER: | 21 CFR 888.3045 |
| CLASSIFICATION PRODUCT CODE: | MQV |
| CLASS: | II |

# III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:

| TABLE 1. Legally Marketed Devices | | | | |
|-----------------------------------|---------|------------------------------|--|--|
| Device Name | 510(k) | Substantial Equivalence Date | | |
| MASTERGRAFT® UltraMatrix | K130335 | 04/19/2013 | | |
| MASTERGRAFT® Strip and | K140375 | 04/18/2014 | | |
| MASTERGRAFT® Putty | | | | |

# IV. DEVICE DESCRIPTION:

MASTERGRAFT® Matrix EXT is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the

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device is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation.

MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip form for single patient use.

The device is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate.

The purpose of this Traditional 510(k) application is the addition of a new contraindication to the Instructions for Use (IFU) for MASTERGRAFT® Matrix EXT.

### V. INDICATIONS FOR USE:

MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps not intrinsic to the stability of the bony structure and can be used as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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. The device resorbs and is replaced with bone during the healing process.

# VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:

| Comparison Feature | Subject<br>MASTERGRAFT® Matrix<br>EXT | Predicate<br>MASTERGRAFT®<br>UltraMatrix |
|---------------------------------------------------------------------------------|---------------------------------------|------------------------------------------|
| Indication for Use | Identical | K130335 (S.E. 04/19/2013) |
| Fundamental Scientific<br>Technology<br>Operating Principle Mechanism of Action | Identical | K130335 (S.E. 04/19/2013) |
| Basic Design | Identical | K130335 (S.E. 04/19/2013) |
| Performance | Identical | K130335 (S.E. 04/19/2013) |
| Manufacturing principles | Identical | K130335 (S.E. 04/19/2013) |

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| Comparison Feature | Subject<br>MASTERGRAFT® Matrix<br>EXT | Predicate<br>MASTERGRAFT®<br>UltraMatrix |
|--------------------------------------------------|---------------------------------------|------------------------------------------|
| Sterilization | Identical | K130335 (S.E. 04/19/2013) |
| Shelf-Life | Identical | K130335 (S.E. 04/19/2013) |
| Packaging | Identical | K130335 (S.E. 04/19/2013) |
| Material Composition<br>• Collagen<br>• Granules | Identical | K130335 (S.E. 04/19/2013) |
| Use of rigid fixation | Identical | K130335 (S.E. 04/19/2013) |
| Safety and Effectiveness<br>profile | Identical | K130335 (S.E. 04/19/2013) |

### VII. DISCUSSION OF NON-CLINICAL TESTING:

Non-clinical testing was performed in support of substantial equivalence for MASTERGRAFT® Strip cleared under K082166 (S.E. 06/02/2009). This data is considered relevant to and supportive of the cited predicate K130335 (S.E. 04/19/2013).

The non-clinical testing was conducted in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. No new non-clinical testing was performed or submitted in support of this 510(k) application.

# VIII. CONCLUSION:

Documentation provided in this submission demonstrates that the subject device is substantially equivalent to the previously cleared bone void filler MASTERGRAFT® UltraMatrix (K130335, SE 04/19/2013) and MASTERGRAFT® Strip and MASTERGRAFT® Putty K140375 (S.E. 04/18/2014).

The subject device is substantially equivalent to predicate MASTERGRAFT® UltraMatrix K130335 (04/19/2013) in several categories including: indication, material composition (including biphasic calcium phosphate granules and collagen), biodegradability, sterility, shelflife, need for rigid fixation, biocompatibility and the ability to resorb during the healing process. The subject device is also substantially equivalent to K140375 (S.E. 04/18/2014) MASTERGRAFT® Strip and MASTERGRAFT® Putty related to the additional contraindication identified in the labeling.