HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM

K062495 · Depuy Spine, Inc. · MQV · Oct 13, 2006 · Orthopedic

Device Facts

• Record ID: K062495
• Device Name: HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HEALOS® FX Bone Graft Substitute ("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. 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 to a surgical site.

Device Story

HEALOS® FX is a resorbable bone graft substitute composed of Type I bovine collagen and hydroxyapatite; intended for use with autogenous bone marrow to fill non-structural skeletal voids. The associated Mixing and Delivery System facilitates the preparation and application of the graft material to the surgical site. Used by surgeons in clinical settings to support natural bone remodeling. The system components include various plastics (Makrolon, ABS, polyethylene) and adhesives. No complex electronics or software involved.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bone graft: Type I bovine collagen and hydroxyapatite. Delivery system materials: Makrolon Rx2530-1118, Cycolac ABS MG47MD, EPDM, cyanoacrylate, polyethylene, acrylic copolymer. Manual delivery mechanism. No energy source or software.

Indications for Use

Indicated for filling non-structural bony voids or gaps in the skeletal system (extremities, spine, pelvis) caused by surgery or trauma in patients requiring bone graft substitutes; 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)
• Vitoss® Scaffold Foam Bone Graft Material (K032288)
• Symphony® Graft Delivery System (K003286)
• Harvest® Graft Delivery System (K043261)
• Imbibe® II Syringe (K030208)

Submission Summary (Full Text)

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K062495 Pg1/2

#### XI. 510(k) Summary

| SUBMITTER: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780<br>Tel: [phone]<br>Fax: [phone] | OCT 13 2006 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Melanie Archer | |
| DATE PREPARED: | August 23, 2006 | |
| CLASSIFICATION NAME: | Resorbable calcium salt bone void filler<br>Piston Syringe | |
| PROPRIETARY NAME: | HEALOS® FX Bone Graft Substitute<br>HEALOS® FX Graft Mixing and Delivery System | |
| PREDICATE DEVICES: | HEALOS® Bone Graft Substitute (K012751 and K043308)<br>Vitoss® Scaffold Foam Bone Graft Material (K032288)<br>Symphony® Graft Delivery System (K003286)<br>Harvest® Graft Delivery System (K043261)<br>Imbibe® II Syringe (K030208) | |

### DEVICE DESCRIPTION:

HEALOS® FX Bone Graft Substitute:

HEALOS® FX Bone Graft Substitute ("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. The principal components of the HEALOS FX Bone Graft Substitute are Type I bovine collagen and hydroxyapatite that are resorbed and remodeled into new bone as part of the natural healing that are

HEALOS® FX Graft Mixing and Delivery System:

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

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Ko6245 1/2

### INTENDED USE:

### HEALOS® FX Bone Graft Substitute:

- HEALOS® FX Bone Graft Substitute ("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. 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 to a surgical site.

### MATERIALS:

HEALOS® FX Bone Graft Substitute: Calcium salt with Type I bovine collagen.

HEALOS® FX Graft Mixing and Delivery System: Makrolon Rx2530-1118, Cycolac ABS MG47MD, EPDM, Loctite cyanoacrylate, polyethylene, acrylic copolymer.

#### PERFORMANCE

#### DATA:

HEALOS® FX Bone Graft Substitute:

A performance evaluation has been included to support the safety and effectiveness of HEALOS®FX compared to the predicate devices.

## HEALOS® FX Graft Mixing and Delivery System:

No performance standards have been established for this type of device. The substantial equivalence of the HEALOS® FX Graft Mixing and Delivery System to the predicate devices (Symphony Graft Delivery System (K003286), Harvest Graft Delivery System (K043261), and Imbibe II Syringe (K030208) is based upon equivalence in design, principles of operation, indications and intended use.

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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, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 3 2006

DePuy Spine, Inc % Ms. Melanie Archer Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K062495

Trade/Device Name: HEALOS® FX Bone Graft Substitute, HEALOS® Graft Mixing and Deliver Systems Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, FMF Dated: August 23, 2006 Received: August 25, 2006

Dear Ms. Archer:

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, and 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 – Ms. Melanie Archer

This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotter will and hyb your e 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours,

For

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

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Indications for Use IV.

KO62495 510(k) Number (if known):

HEALOS® FX Bone Graft Substitute Device Name: HEALOS® FX Graft Mixing and Delivery System

HEALOS® FX Bone Graft Substitute Indications For Use:

HEALOS® FX Bone Graft Substitute ("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. 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 to a surgical site.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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 Sign-Off) Division of General, Restorative. and Neurological Devices

14062493 510(k) Number

DePuy Spine, Inc.