MODIFICATION TO: HEALOS BONE GRAFT MATERIAL

K043308 · Depuy Spine, Inc. · MQV · Feb 16, 2005 · Orthopedic

Device Facts

• Record ID: K043308
• Device Name: MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
• Applicant: Depuy Spine, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HEALOS Bone Graft Material ("HEALOS"), 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 should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.

Device Story

HEALOS Bone Graft Material is a resorbable bone void filler composed of Type I bovine collagen and hydroxyapatite. It is intended for use by surgeons to fill non-structural osseous defects in the extremities, spine, and pelvis. The material is mixed with autogenous bone marrow prior to implantation. Once placed, the device acts as a scaffold that is resorbed and remodeled into new bone through natural physiological processes. This submission specifically covers the addition of new dimensional and volumetric configurations to the existing product line.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Materials: Type I bovine collagen and hydroxyapatite. Form factor: Preformed pellets/configurations for bone void filling. Resorbable bone void filler. No performance standards established.

Indications for Use

Indicated for filling non-structural bony voids or gaps in the extremities, spine, and pelvis caused by surgery or trauma. Contraindicated for large defects where spontaneous healing is unlikely. 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 Material (K012751)

Submission Summary (Full Text)

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Ko43308

FEB 1 6 2005

## IX. 510(k) Summary

DePuy Spine, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780

Sharon Starowicz CONTACT PERSON:

November 5, 2004 DATE PREPARED:

CLASSIFICATION NAME: Filler, calcium sulfate preformed pellets

PROPRIETARY NAME: HEALOS Bone Graft Material

PREDICATE DEVICES: HEALOS Bone Graft Material (K012751)

Addition of dimensional and volumetric configurations DEVICE DESCRIPTION: to the HEALOS Bone Graft Material

HEALOS Bone Graft Material ("HEALOS"), combined INTENDED USE: 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 should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.

The principal components of HEALOS are Type I MATERIALS: bovine collagen and hydroxyapatite.

PERFORMANCE No performance standards have been established for DATA: this type of device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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FEB 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sharon Starowicz Director of Regulatory Affairs DePuv Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K043308

Trade/Device Name: HEALOS® Bone Graft Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: January 21, 2005 Received: January 24, 2005

Dear Ms. Starowicz:

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 r ou may) after or visions 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 may oe subject to back acceral 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 or any I 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Starowicz

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin mailing of substantial equivalence of your device to a legally premaired notification: The PPA mailing of 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 If you desire specific advice ion Jour [phone]. Also, please note the regulation entitled, Comact the Office of Compullion as (21 notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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 A. Milliken

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## lll. Indications for Use

510(k) Number (if known):

HEALOS® Bone Graft Material Device Name:

Indications For Use:

HEALOS Bone Graft Material ("HEALOS"), 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 should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.

Prescription Use (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)

Page 1 of _

Mark A. Milam

General, Restorative. and Neurological Devices

510(k) Number K043308