HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015

K081758 · Depuy Spine, Inc. · MQV · Sep 3, 2008 · Orthopedic

Device Facts

• Record ID: K081758
• Device Name: HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
• Applicant: Depuy Spine, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HEALOS® Fx Injectable Bone Graft Replacement ("HEALOS Fx"), combined with autogenous bone marrow is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural healing process. The HEALOS® Fx Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS Fx Injectable Bone Graft Replacement to a surgical site.

Device Story

HEALOS Fx is a mineralized collagen matrix (Type I bovine collagen and hydroxyapatite, 20-30% mineral by weight) used as a bone void filler. The system includes a mixing and delivery kit with two chambers. In a surgical setting, a physician mixes the HEALOS Fx material with autogenous bone marrow aspirate using the provided mixing chamber. The resulting graft mixture is delivered to the surgical site via the delivery chamber. The material acts as a scaffold, resorbing and remodeling into new bone during the natural healing process. The device is intended for non-load-bearing skeletal defects.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Material: Type I bovine collagen and hydroxyapatite (20-30% mineral by weight). Delivery system: Copolymer and plastic materials. Form factor: Lyophilized fibrous material for surgical implantation. Delivery mechanism: Piston syringe-style mixing and delivery chambers.

Indications for Use

Indicated for patients requiring bone void filling in the extremities, spine, or pelvis for defects not intrinsic to bony stability, including surgically created or traumatic osseous defects. Used in combination 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

• HEALOS® Bone Graft Substitute (K012751 and K043308)
• HEALOS® Fx Bone Graft Substitute (K062495)
• HEALOS® Fx Graft Mixing and Delivery System (K062495)
• Symphony® Graft Delivery System (K003286)
• Harvest® Graft Delivery System (K043261)
• Imbibe® II Syringe (K030208)

Submission Summary (Full Text)

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K081758
(pg. 1 of 2)

## 510(K) SUMMARY 5.

| Submitter: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 | SEP - 3 2008 |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Hande Tufan<br>Sr. Regulatory Affairs Associate<br>Voice:     [phone]<br>Fax:         [phone]<br>E-Mail:     [e-mail] | |
| Date Prepared: | June 19, 2008 | |
| Device Class: | Class II | |
| HEALOS® Fx Device<br>Classification Name: | Resorbable calcium salt bone void filler<br>§888.3045 | |
| HEALOS® Fx Graft<br>Mixing and Delivery<br>System Classification Name: | Piston Syringe<br>§880.5860 | |
| Classification Panel: | Orthopedic | |
| FDA Panel Number: | 87 | |
| Product Code(s): | MQV and FMF | |
| Proprietary Name: | HEALOS® Fx Injectable Bone Graft Replacement<br>HEALOS® Fx Graft Mixing and Delivery System | |
| Predicate Devices:<br>(Material) | HEALOS® Bone Graft Substitute (K012751 and K043308)<br>HEALOS® Fx Bone Graft Substitute (K062495) | |
| (Mixing/Delivery device) | HEALOS® Fx Graft Mixing and Delivery System<br>(K062495)<br>Symphony® Graft Delivery System (K003286)<br>Harvest® Graft Delivery System (K043261)<br>Imbibe® II Syringe (K030208) | |
| Device Description: | HEALOS Fx Injectable Bone Graft Replacement is a<br>mineralized collagen matrix processed into lyophilized<br>fibrous material for surgical implantation. The principal<br>components of the HEALOS Fx Injectable Bone Graft<br>Replacement are Type I bovine collagen and<br>hydroxyapatite. HEALOS Fx is approximately 20-30%<br>mineral by weight. | |
| | The HEALOS Fx Graft Mixing and Delivery System is<br>designed to facilitate the mixing of autogenous bone<br>marrow aspirate with the HEALOS Fx material and to<br>deliver this bone graft mixture into the surgical site.<br>Included in the kit are two chambers: a mixing chamber and<br>a delivery chamber. | |
| Intended Use: | HEALOS® Fx Injectable Bone Graft Replacement<br>("HEALOS Fx"), combined with autogenous bone marrow<br>is intended for use in filling bony voids or gaps of the<br>skeletal system (i.e., the extremities, spine, and pelvis) that<br>are not intrinsic to the stability of the bony structure. These<br>defects may be surgically created osseous defects or<br>osseous defects resulting from traumatic injury to the bone.<br>The product provides a bone void filler that is resorbed and<br>remodeled into new bone as part of the natural healing<br>process. | |
| | The HEALOS® Fx Graft Mixing and Delivery System is<br>indicated for the mixing and delivery of HEALOS Fx<br>Injectable Bone Graft Replacement to a surgical site. | |
| Materials: | The principal components of HEALOS Fx Injectable Bone<br>Graft Replacement are Type I bovine collagen and<br>hydroxyapatite. | |
| | The principal components of the HEALOS Fx Graft<br>Mixing and Delivery System are copolymer and plastic<br>materials. | |
| Performance Data: | No performance standards have been established for this<br>type of device. | |

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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2008

Dupuy Spine, Inc. % Mr. Hande Tufan Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K081758

Trade/Device Name: HEALOS® Fx Injectable Bone Graft Replacement HEALOS® Fx Graft Mixing and Delivery System Regulation Number: 21 CFR 888.3045 Regulation Names: Resorbable calcium salt bone void filler device. Regulatory Class: II Product Code: MQV, FMF Dated: June 19, 2008 Received: June 20, 2008

Dear Mr. Tufan:

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 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 - Mr. Hande Tufan

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 Postmarket, Surveillance 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 general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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 4.

081758 510(k) Number (if known):

Device Name: HEALOS® Fx Injectable Bone Graft Replacement HEALOS® Fx Graft Mixing and Delivery System

HEALOS® Fx Injectable Bonc Graft Replacement Indications For Use:

HEALOS® Fx Injectable Bone Graft Replacement ("HEALOS Fx"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may he surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS Fx is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.

HEALOS® Fx Graft Mixing and Delivery System Indications for Use:

The HEALOS® Fx Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® Fx Injectable Bone Graft Replacement to a surgical site.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K081385

DePuy Spine, Inc. Traditional 510(k) Submission