SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX

K083742 · Collagen Matrix, Inc. · LYC · Feb 12, 2009 · Dental

Device Facts

• Record ID: K083742
• Device Name: SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
• Applicant: Collagen Matrix, Inc.
• Product Code: LYC · Dental
• Decision Date: Feb 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthetic Mineral - Collagen Bone Graft Matrix is intended for use in dental surgery. The products may be used in surgical procedures such as: - Augmentation or reconstructive treatment of alveolar ridge . - Filling of periodontal defects . - Filling of defects after root resection, apicocectomy, and cystectomy . - Filling of extraction sockets to enhance preservation of the alveolar ridge . - Elevation of maxillary sinus floor . - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration

Device Story

Composite bone graft matrix; synthetic calcium phosphate granules with bovine type I collagen. Osteoconductive, resorbable, porous material; supplied as granules, blocks, or plugs. Used in dental surgery by clinicians for bone defect filling and ridge augmentation. Provides scaffold for bone growth; facilitates healing in periodontal and peri-implant sites. Sterile, single-use device.

Clinical Evidence

No clinical data. Safety and effectiveness established via in vitro product characterization studies and in vivo biocompatibility testing per FDA Blue Book guidelines.

Technological Characteristics

Composite of synthetic calcium phosphate (apatite structure) and bovine Achilles tendon-derived type I collagen. Resorbable, porous matrix. Supplied as sterile, non-pyrogenic granules, blocks, or plugs for single use. No electronic or software components.

Indications for Use

Indicated for dental surgery patients requiring bone grafting for alveolar ridge augmentation/reconstruction, periodontal defect filling, root resection/apicocectomy/cystectomy defect filling, extraction socket preservation, maxillary sinus floor elevation, or peri-implant defect filling (often with GTR/GBR products).

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

• SynOss™ Synthetic Bone Graft Material (K072397)
• OsteoGuide™ Anorganic Bone Mineral Products (K043034)
• FOUNDATION™ Bone Filling Augmentation Material (K040783)

Submission Summary (Full Text)

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K083742

FEB 1 2 2009

## 510(k) Summary of Safety and Effectiveness

Applicant Name and Address: Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Peggy Hansen, RAC Contact Person: Sr. Director, Clinical, Regulatory, and QA Tel: [phone] Fax: [phone]

December 12, 2008 Date of Summary:

Bone Grafting Material Device Common Name:

Synthetic Mineral - Collagen Bone Graft Matrix Device Trade Name:

Device Classification Name:

Bone Grafting Material, Synthetic 872.3930 LYC Class II

Predicate Device(s):

SynOss™ Synthetic Bone Graft Material K072397 OsteoGuide™ Anorganic Bone Mineral Products K043034 FOUNDATION™ Bone Filling Augmentation Material K040783

#### Description of the Device

Synthetic Mineral -- Collagen Bone Graft Matrix is a composite of synthetic calcium phosphate based granules and type I collagen. The calcium phosphate mineral has an apatite structure similar to that of natural bone. The type I collagen is derived from bovine Achilles tendon. The composite material is a resorbable, porous, osteoconductive bone graft matrix. The product is supplied in granular or block/plug form, and it is sterile, non-pyrogenic, and for single use only.

#### Intended Use

Synthetic Mineral - Collagen Bone Graft Matrix is intended for use in dental surgery. The products may be used in surgical procedures such as:

- Augmentation or reconstructive treatment of alveolar ridge .
- Filling of periodontal defects .
- Filling of defects after root resection, apicocectomy, and cystectomy .
- Filling of extraction sockets to enhance preservation of the alveolar ridge �
- Elevation of maxillary sinus floor .

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- Filling of periodontal defects in conjunction with products intended for Guided � Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided . � Bone Regeneration

# Summary/Comparison of Technical Characteristics

Synthetic Mineral – Collagen Bone Graft Matrix and its predicates have the same Gynthello Mineral - Seriatics. In particular, the Synthetic Mineral - Collagen Bone Graft Matrix and its predicates are the same with respect to intended use, material characterization, and product forms.

#### Safety

Synthetic Mineral – Collagen Bone Graft Matrix has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book to assess to oalery.blooompanisms.com the biological evaluation of medical devices.

#### Effectiveness

The characteristics of the Synthetic Mineral – Collagen Bone Graft Matrix meet the design requirements for an effective bone grafting material in dental surgery.

#### Conclusion

The results of the in vitro product characterization studies, in vitro and in vivo The Tesults of the in Vitro product than Synthetic Mineral – Collagen Bone Graft Matrix is safe and substantially equivalent to OsteoGuide Anorganic Bone Mineral with Collagen.

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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. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 2 2009

Ms. Peggy Hansen President, Clinical, Regulatory, QA, and Marketing Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K083742

Trade/Device Name: Synthetic Mineral - Collagen Bone Graft Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: LYC, NPM Dated: December 12, 2008 Received: December 16, 2008

Dear Ms. Hansen:

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. Hansen

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" (21 CFR 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 vours.

Anthony D. Orain
Ginette V. Michaud, M.D.

Ginette Y. Michaud, M Acting 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

K083742

510(k) Number (if known):

Device Name: _ Synthetic Mineral - Collagen Bone Graft Matrix

Indications for Use:

Synthetic Mineral - Collagen Bone Graft Matrix is intended for use in dental surgery ... The products may be used in surgical procedures such as:

- Augmentation or reconstructive treatment of alveolar ridge
- Filling of periodontal defects .
- Filling of defects after root resection, apicocectomy, and cystectomy .
- Filling of extraction sockets to enhance preservation of the alveolar ridge .
- Elevation of maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration

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)

Super Tunne
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devicess

510(k) Number: K083742

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