CLEARED UNDER GRAFTON II EDBM

K122513 · Medtronic Sofamor Danek, Inc. · MBP · Mar 6, 2013 · Orthopedic

Device Facts

• Record ID: K122513
• Device Name: CLEARED UNDER GRAFTON II EDBM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MBP · Orthopedic
• Decision Date: Mar 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

Device Story

MAGNIFUSE® II Bone Graft is a bone void filler composed of human bone allograft tissue matrix. Clinicians assemble the device intraoperatively by mixing the allograft 1:1 with autograft tissue. The mixture is packed into a resorbable polyglycolic acid (PGA) mesh bag using provided plastic tools (spatula, funnel, plunger). The device is used in surgical settings to fill bony voids or gaps in the skeletal system, such as the posterolateral spine or pelvis. It acts as a scaffold that is resorbed and remodeled by host bone during the healing process. The device provides a physical construct for bone grafting, aiding in the repair of surgically created or traumatic defects. It is intended for prescription use by surgeons.

Clinical Evidence

No human clinical data provided. Evidence consists of a rabbit posterolateral lumbar fusion study comparing the subject device to autograft. Results showed fusion rates for the subject device were comparable to the autograft group. Osteoinductivity was confirmed via a validated athymic rat surrogate assay using a five-point linear scale for bone formation at 28 days post-implantation.

Technological Characteristics

Materials: Human bone allograft tissue, polyglycolic acid (PGA) resorbable mesh. Form factor: Mesh bag construct. Sterilization: USP <71> compliant. Processing: Proprietary demineralization, alcohol soaks, and supercritical CO2 dehydration for viral inactivation. No electronic or software components.

Indications for Use

Indicated for use as a bone graft substitute in bony voids or gaps of the skeletal system (e.g., posterolateral spine and pelvis) not intrinsic to structural stability. Applicable to surgically created defects or traumatic bone injuries.

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

• Grafton® II eDBM (K082615)

Reference Devices

• MAGNIFUSE® Bone Graft (K082165)
• GRAFTON® DBM (K051195)
• K061982

Submission Summary (Full Text)

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177511 113

# MAR 0 6 2013

### 510(K) Summary

#### SUBMITTER NAME AND ADDRESS: l.

Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 [phone] Telephone: [phone] Fax: Establishment Registration: 1030489

Kelly Anglin Sr. Regulatory Affairs Specialist

February 14, 2013

#### II. PROPOSED PROPRIETARY TRADE NAME:

DEVICE CLASSIFICATION NAME:

REGULATION NUMBER: REGULATION NAME:

CONTACT PERSON:

DATE PREPARED:

REGULATORY CLASS: PRODUCT CODE:

### MAGNIFUSE® II BONE GRAFT

Filler, bone void, calcium compound 21 CFR 888.3045 Resorbable calcium salt bone void filler device MQV, MBP

#### IDENTIFICATION OF LEGALLY MARKETED DEVICES: III. Grafton® II eDBM (K082615, SE 10/16/2008)

#### IV. DEVICE DESCRIPTION:

MAGNIFUSE® II Bone Graft is assembled by the clinician at the time of the procedure using the supplied human bone allograft tissue matrix mixed 1:1 with autograft tissue. The mixture is packed into a polyglycolic acid (PGA) resorbable mesh bag with the supplied injection molded plastic spatula, funnel, and plunger. This product enables clinicians to generate a construct having a particular physical form and handling property. No additional carrier is added to the allograft material.

This MAGNIFUSE® II Bone Graft product was prepared from human bone tissue recovered from a cadaveric donor using aseptic surgical techniques and microbiologically tested during recovery. As a biological material, some variations in the product should be expected in both handling and appearance. The final product in packaged form was tested for sterility according to the procedures in the current U.S. Pharmacopoeia USP standard <71>.

### V. INDICATIONS FOR USE:

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MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

| Characteristic | Subject Device:<br>MAGNIFUSE® II Bone<br>Graft | Predicate Device<br>GRAFTON® II eDBM |
|---------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------|
| Product<br>Preparation<br>Instruction | Addition of autograft<br>to mesh bag using<br>provided spatula,<br>funnel and syringe | K082615<br>(SE 10/16/2008) |
| Operating<br>Principle | Identical | K082615<br>(SE 10/16/2008) |
| Basic Design | Identical | K082615<br>(SE 10/16/2008) |
| Performance | Identical | K082615<br>(SE 10/16/2008) |

#### SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS: VI.

#### SUMMARY OF NON-CLINICAL TESTING VIII.

A Rabbit posterlateral lumbar fusion study was conducted to evaluate the bone formation capability of MAGNIFUSE® II Bone Graft. The autograft group fusion rates were consistent with the literature and previous laboratory results in this model, suggesting a valid fusion test. The predicate MAGNIFUSE ® Bone Graft manual fusion rate was equal to autograft rate but the radiographic fusion rate was higher with MAGNIFUSE ® Bone Graft. The fusion rates for the subject MAGNIFUSE ® Il Bone Graft exhibited comparable fusion rates to the autograft group. All animals tolerated the graft material well and exhibited remodeling of the graft site over the duration of the study.

The allograft tissue supplied as a subcomponent of the subject MAGNIFUSE ® Il Bone Graft device is identical in form and processing to the predicate MAGNIFUSE ® device cleared under eDBM K082165 (S.E. 10/16/2008). Methods employed to ensure osteoinductivity and viral inactivation of the allograft component are described in further detail in K082615 and subsequent submissions that were cleared by the agency. The allograft tissue subcomponent will be processed via a proprietary processing method that has been shown to consistently produce demineralized bone matrix that is osteoinductive in an athymic rat assay. As the tissue processing is identical to the predicate MAGNIFUSE® device, process consistency for MAGNIFUSE ® II will be confirmed via ongoing testing of the MAGNIFUSE ® finished product for osteoinductivity in this validated athymic rat assay utilizing a five-point linear scale (0, 1, 2, 3, 4) to score

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bone formation at 28 days post implantation*. Bone formation in the athymic rat surrogate assay should not be interpreted as a predictor of clinical performance. A full assessment of osteoinductivity of the MAGNIFUSE ® device can be found in K082615. Viral inactivation of MAGNIFUSE® II allograft fibers includes proprietary processing steps of demineralizing acid soaks followed by alcohol soaks and dehydration, as established for the GRAFTON® DBM products (K051195).

Viral inactivation of the cortical chips is done by alcohol soaks and by dehydration using supercritical CO2 established for viral inactivation cleared in (K061982). These processing steps have been shown and validated to inactivate viruses including; HIV-1; hepatitis B virus; hepatitis C virus, CMV, and Polio virus. These processes further reduce the risk of disease transmission via the use of this product beyond the protection provided by donor testing and screening procedures.

* Edwards etal; Osteoinduction of Human Demineralized Bone: Characterization in a Rat Model.

Clinical Orthopaedics, December 1998, Vol 357.

- VII. CONCLUSION:
The design features for the subject MAGNIFUSE® II Bone Graft are substantially equivalent to the predicate. Based on the risk analysis and additional supporting documentation provided in this premarket notification, Medtronic believes the subject device demonstrates substantial equivalence to listed predicate device GRAFTON® II eDBM K082165 (S.E. 10/16/2008).

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol that resembles a human figure embracing or supporting another, represented by flowing, abstract shapes.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## March 6, 2013

Medtronic Sofamor Danek USA, Incorporated % Ms. Kelly Anglin Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K122513

Trade/Device Name: MAGNIFUSE® II Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: February 14, 2013 Received: February 19, 2013

Dear Ms. Anglin:

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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## Page 2 - Ms. Kelly Anglin

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the name "Erin DKeith" in a stylized font. The letters "Erin" and "eith" are in a simple, bold font. The letters "DK" are more stylized, with a circular design in the middle of the "D".

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Device Name: MAGNIFUSE® II Bone Graft

### INDICATIONS FOR USE:

MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122513