MASTERGRAFT STRIP

K082166 · Medtronic Sofamor Danek · MQV · Jun 2, 2009 · Orthopedic

Device Facts

• Record ID: K082166
• Device Name: MASTERGRAFT STRIP
• Applicant: Medtronic Sofamor Danek
• Product Code: MQV · Orthopedic
• Decision Date: Jun 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or qaps 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 or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Device Story

MASTERGRAFT® Strip is a sterile, biocompatible, osteoconductive, porous bone void filler. Composition: purified Type I collagen (>95%) and biphasic calcium phosphate ceramic (15% hydroxyapatite, 85% beta-tricalcium phosphate). Device absorbs autogenous bone marrow aspirate or is mixed with autograft; packed into skeletal bony voids or gaps by surgeons. Implant acts as a scaffold for bony ingrowth; resorbs over time as it is replaced by natural bone. Used in orthopedic procedures to treat surgically created or traumatic osseous defects.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and material properties.

Technological Characteristics

Bioresorbable implant; composition: >95% purified Type I collagen and biphasic calcium phosphate (15% hydroxyapatite/85% beta-tricalcium phosphate). Form factor: premixed strip. Osteoconductive, porous structure. Sterile, single-patient use.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (posterolateral spine, pelvis, ilium, extremities) not intrinsic to structural stability. Used with autogenous bone marrow or autograft as a bone graft extender 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

• MASTERGRAFT® Matrix (K023553)
• MASTERGRAFT® Putty (K071813)
• OssiMend Bone Graft Material (K052812)
• Collagraft Strip Bone Graft Material (K000122)
• Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124)

Submission Summary (Full Text)

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# Medtronic Sofamor Danek MASTERGRAFT® Strip 510(K) Summary July 2008

JUN - 2 2009

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

> Contact: Michelle Obenauer Regulatory Affairs Manager

- II. Proposed Proprietary Trade Name: MASTERGRAFT® Strip Classification Name: filler device
Product Code: Regulation No .: Resorbable calcium salt bone void MQV 888.3045

#### lll. Product Description/Purpose of Application

MASTERGRAFT® Strip is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip device, the collagen is a highly purified (s95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of all devices is provided in a 15% hydroxyapatite and 85% b-tricalcium phosphate formulation.

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

MASTERGRAFT® Strip 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 and has been shown to heal bone defects.

The purpose of this 510(k) application is to add MASTERGRAFT® Strip to the MASTERGRAFT® family of products. Like the previously cleared

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predicates, MASTERGRAFT® Matrix (K023553, SE 04/22/2003, bone void filler) and MASTERGRAFT® Putty (K071813, SE 11/09/07, autograft extender ), the subject system is intended to be combined with autogenous bone marrow as a bone void filler for bony voids or qaps that are not intrinsic to the stability of the bony structure. In addition, MASTERGRAFT® Strip can be mixed with autogenous bone and used as a bone graft extender.

### IV. Indications

MASTERGRAFT® Strip 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; MASTERGRAFT® Strip can also be used with autograft 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, illium, 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.

## Substantial Equivalence V.

Documentation is provided that demonstrates MASTERGRAFT® Strip to be substantially equivalent to the previously cleared MASTERGRAFT® Matrix (K023553), MASTERGRAFT® Putty (K071813), OssiMend Bone Graft Material (K052812), Collagraft Strip Bone Graft Material (K000122) and Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek % Ms. Michelle Obenauer Regulatory Affairs Manager 1800 Pyramid Place Memphis, Tennessee 38132

## JUN - 2 2009

Re: K082166

Trade/Device Name: MASTERGRAFT® Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: II Product Code: MOV Dated: May 21, 2009 Received: May 22, 2009

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 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 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 forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2-Ms. Michelle Obenauer

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): KO82)66

Device Name: MASTERGRAFT® Strip

## Indications for Use:

MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or qaps 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 or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use પ્ર Per 21 CFR 801.109

OR

Over-The-Counter Use

Signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K082166

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