HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025

K093390 · Depuy Spine, Inc. · LYC · May 25, 2010 · Dental

Device Facts

• Record ID: K093390
• Device Name: HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
• Applicant: Depuy Spine, Inc.
• Product Code: LYC · Dental
• Decision Date: May 25, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HEALOS Dental Bone Graft Substitute is intended to fill, augment, or reconstruct periodontal and/or bony defects of the upper or lower jaw. HEALOS is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.

Device Story

HEALOS Dental Bone Graft Substitute is a mineralized collagen matrix composed of Type I bovine collagen and hydroxyapatite (approx. 30% mineral by weight). It is processed into lyophilized strips or pads for surgical implantation. The device is used by clinicians to fill, augment, or reconstruct periodontal or bony defects in the upper or lower jaw. It functions as a scaffold that is resorbed and remodeled into new bone during the natural healing process. This submission introduces additional size configurations for the existing device formulation.

Clinical Evidence

No clinical data. Preclinical testing was performed to verify that the subject device possesses the same characteristics as the predicate device.

Technological Characteristics

Mineralized collagen matrix; Type I bovine collagen and hydroxyapatite; 30% mineral by weight; lyophilized strips or pads; non-resorbable/resorbable bone graft substitute.

Indications for Use

Indicated for filling, augmenting, or reconstructing periodontal and/or bony defects of the upper or lower jaw in patients requiring bone graft substitutes.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• HEALOS Dental Bone Graft Substitute (K081432)

Submission Summary (Full Text)

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K093390

MAY 2 5 2010

510(k) Summary

Submitter: DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767

- Contact Person: Sharon Starowicz Director of Regulatory Affairs Voice: [phone] Fax: [phone] E-Mail: sstarow 1 @ its. jnj.com
Date Prepared: April 27, 2010

Device Class: Class II

Classification Name: Bone grafting material \$872.3930

Classification Panel: Dental

FDA Panel Number: 76

Product Code(s): LYC and NPM

Proprietary Name: HEALOS Dental Bone Graft Substitute

Predicate Devices: HEALOS Dental Bone Graft Substitute (K081432)

Device Description: HEALOS Dental Bone Graft Substitute is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of the HEALOS Dental Bone Graft Substitute are Type I bovine collagen and hydrox yapatite. HEALOS Dental Bone Graft Substitute is approximately 30% mineral by weight. The subject of this 510(k) is to add additional size configurations. The formulation is identical to the predicate device- HEALOS Dental Bone Graft Substitute. There are no changes to the material, chemical composition, physical structure, or indications for use of the product.

Intended Use: HEALOS Dental Bone Graft Substitute is intended to fill, augment, or reconstruct periodontal and/or bony defects of the upper or lower jaw. HEALOS is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.

Materials: The principal components of HEALOS Dental Bone Graft Substitute are Type I bovine collagen and hydroxyapatite.

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Performance Data: No performance standards have been established for this type of device. Preclinical testing has been completed to verify the subject device has the same characteristics as the predicate device.

Conclusion: Based on the predicate comparison and testing, the subject device HEALOS Dental Bone Graft Substitute is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

## Public Health Service

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

MAY 2 & 2010

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

Re: K093390

Trade/Device Name: HEALOS Dental Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC, NPM Dated: April 27, 2010 Received: April 28, 2010

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 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.

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Page 2- Ms. Starowicz

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 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.

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.html 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Th for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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K093390

## 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: HEALOS Dental Bone Graft Substitute

Indications For Use:

HEALOS Dental Bone Graft Material ("HEALOS"), is intended to fill, augment, or reconstruct periodontal and/or bony defects of the upper or lower jaw. HEALOS is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.

Reim Kelly for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _K 09339C

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)