MODIFICATION TO:MICROFUSE BONE VOID FILLER

K083232 · Globus Medical, Inc. · MQV · Dec 24, 2008 · Orthopedic

Device Facts

• Record ID: K083232
• Device Name: MODIFICATION TO:MICROFUSE BONE VOID FILLER
• Applicant: Globus Medical, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Dec 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities, spine and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

MicroFuse™ Bone Void Filler is a porous scaffold for bone repair; composed of bonded poly(lactide-co-glycolide) or poly(lactic acid) microspheres; optional additives include barium sulfate and calcium sulfate. Available as granules, sheets, or pre-formed blocks for varying defect types; granules packed into voids; sheets used for shallow defects or onlays; blocks fill entire defects. Implanted by surgeons in clinical settings to fill osseous defects not intrinsic to bony stability. Device resorbs over time, facilitating replacement with natural bone during healing. Provides structural scaffold for bone growth; intended for use with autograft or bone marrow aspirate.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design, material, and performance characteristics.

Technological Characteristics

Porous scaffold composed of poly(lactide-co-glycolide) or poly(lactic acid) microspheres. Optional additives: barium sulfate, calcium sulfate. Available in granule, sheet, and block form factors. Resorbable material. No energy source or software components.

Indications for Use

Indicated for filling non-structural bony voids or gaps in the extremities, spine, and pelvis caused by surgery or traumatic injury. Used in combination with autograft or bone marrow aspirate.

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

• MicroFuse™ Bone Void Filler (K071187)
• MicroFuse™ Bone Void Filler (K082442)

Submission Summary (Full Text)

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# 510(k) Summary: MicroFuse™ Bone Void Filler

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>[phone] | DEC 24 2008 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Kelly J. Baker, Ph.D.<br>Director, Clinical Affairs & Regulatory | |
| Device Name: | MicroFuse™ Bone Void Filler | |
| Classification: | Per 21 CFR §888.3045: Resorbable Calcium Salt Bone<br>Void Filler. Class II. The Product Code is MQV. The Panel<br>Code is 87. | |
| Predicate(s): | MicroFuse™ Bone Void Filler (K071187, K082442) and<br>other legally marketed predicate devices | |

### Device Description:

MicroFuse™ Bone Void Filler is a porous bone graft scaffold composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres. MicroFuse™ is available with and without a combination of barium sulfate and calcium sulfate. MicroFuse™ is provided in a variety of shapes and sizes, in the form of granules, sheets, and pre-formed blocks. MicroFuse™ granules are designed to be gently packed into contained voids or defects. MicroFuse™ sheets are designed to be used with shallow bony defects, or as a bone graft onlay to cover a defect. MicroFuse™ blocks are designed to fill an entire defect. MicroFuse™ implants are available in short-term (ST), mid-term (MT), or long-term (LT) compositions.

#### Intended Use:

MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities, spine and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

### Basis of Substantial Equivalence:

The MicroFuse™ Bone Void Filler is similar to the predicate device with respect to design, indications for use, principles of operation, and performance.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 2008

Globus Medical Inc. % Ms. Kelly J. Baker 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K083232

Trade/Device Name: MicroFuse™ Bone Void Filler Regulation Number: 21 CFR 888. 3045 Regulation Name: Resorbable calcium salt bone voice filler device Regulatory Class: II Product Code: MQV Dated: October 31, 2008 Received: November 3, 2008

Dear Ms. Baker:

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 includions for use stated in the enclosure) to legally marketed prodicate 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

II 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 100-1050.

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Page 2 – Ms. Kelly J. Baker

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Presmarket Survcillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other gencral 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 M. Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number:

MicroFuse™ Bone Void Filler Device Name:

#### Indications:

MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities, spine and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

Prescription Use × (Per 21 CFR §801.109) OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Of Overes 12083232

510(k) Number-