HEALOS II BONE GRAFT SUBSTITUTE

K081432 · Depuy Spine, Inc. · LYC · Aug 29, 2008 · Dental

Device Facts

• Record ID: K081432
• Device Name: HEALOS II BONE GRAFT SUBSTITUTE
• Applicant: Depuy Spine, Inc.
• Product Code: LYC · Dental
• Decision Date: Aug 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HEALOS Bone Graft Material ("HEALOS") is intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.

Device Story

HEALOS is a mineralized collagen matrix provided as lyophilized strips or pads for surgical implantation. Composed of Type I bovine collagen and hydroxyapatite (approx. 30% mineral by weight). Used by clinicians in dental/periodontal procedures to fill or reconstruct bony defects in the jaw. Acts as a scaffold for bone void filling; resorbed and remodeled into new bone via natural physiological processes. No electronic or mechanical components.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Mineralized collagen matrix; Type I bovine collagen and hydroxyapatite; ~30% mineral by weight; lyophilized strips or pads; non-electronic; non-software; sterile.

Indications for Use

Indicated for filling, augmenting, or reconstructing periodontal or bony defects of the upper or lower jaw in patients requiring bone void fillers.

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 Bone Graft Substitute (K012751, K043308)
• Novabone Putty Resorbable Bone Void Filler (K051617)
• NovaBone Dental Putty (K063596)
• Bio-Oss Collagen Blocks (K033815)
• Orthoss Resorbable Bone Void Filler (K014289)
• Collagraft Strip Bone Graft Matrix (K000122)

Submission Summary (Full Text)

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K081432

## 1. 510(K) SUMMARY

|| |

| Submitter: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 | | AUG 29 2008 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------|
| Contact Person: | Hande Tufan<br>Sr. Regulatory Affairs Associate | Voice: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] | |
| Date Prepared: | August 25, 2008 | | |
| Device Class: | Class II | | |
| | Classification Name: Bone grafting material<br>§872.3930 | | |
| Classification Panel: Dental | | | |
| FDA Panel Number: 76 | | | |
| Product Code(s): | LYC | | |
| Proprietary Name: | HEALOS Bone Graft Substitute | | |
| Predicate Devices: | HEALOS Bone Graft Substitute (K012751, K043308)<br>Novabone Putty Resorbable Bone Void Filler (K051617)<br>NovaBone Dental Putty (K063596)<br>Bio-Oss Collagen Blocks (K033815)<br>Orthoss Resorbable Bone Void Filler (K014289)<br>Collagraft Strip Bone Graft Matrix (K000122) | | |
| Device Description: | HEALOS is a mineralized collagen matrix processed<br>into lyophilized strips or pads for surgical implantation.<br>The principal components of the HEALOS Bone Graft<br>Substitute are Type I bovine collagen and<br>hydroxyapatite. HEALOS is approximately 30%<br>mineral by weight. | | |
| Intended Use: | HEALOS Bone Graft Material ("HEALOS") is<br>intended to fill, augment, or reconstruct periodontal<br>and or bony defects of the upper or lower jaw. The<br>product provides a bone void filler that is resorbed and<br>remodeled into new bone as part of the natural process. | | |

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

Performance Data: No performance standards have been established for this type of device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 9 2008

Ms. Hande Tufan Senior Regulatory Affairs Associate DePuy Spine, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767

Re: K081432

Trade/Device Names: HEALOS Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC, NPM Dated: August 27, 2008 Received: August 28, 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.

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## Page 2 - Ms. Tufan

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.

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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,

Swaunns
Chiu Lin, Ph.D.

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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K081432

Device Name: HEALOS Bone Graft Substitute

Indications For Use:

HEALOS Bone Graft Material ("HEALOS") is intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.

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)

Susan Rumsey
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K061422