SYNOSS SYNTHETIC BONE GRAFT MATERIAL

K072397 · Collagen Matrix, Inc. · LYC · Oct 18, 2007 · Dental

Device Facts

• Record ID: K072397
• Device Name: SYNOSS SYNTHETIC BONE GRAFT MATERIAL
• Applicant: Collagen Matrix, Inc.
• Product Code: LYC · Dental
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SynOss Synthetic Bone Graft Material 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

SynOss is an osteoconductive, calcium phosphate-based synthetic bone graft material with an apatite structure mimicking human bone. Supplied as sterile, non-pyrogenic granules for single-use in dental surgical procedures. Used by dental surgeons to fill bone defects, augment alveolar ridges, or elevate the maxillary sinus floor. Acts as a scaffold to support bone regeneration; often used in conjunction with GTR/GBR products. Provides a biocompatible matrix for new bone growth, aiding in structural restoration of dental sites.

Clinical Evidence

No clinical data. Safety and effectiveness established via in vitro product characterization and in vitro/in vivo biocompatibility testing.

Technological Characteristics

Calcium phosphate-based bone graft material; apatite structure; granular form; sterile; non-pyrogenic; single-use. Biocompatibility testing performed per ISO 10993-1 and FDA Blue Book Memorandum G95-1.

Indications for Use

Indicated for dental surgery patients requiring alveolar ridge augmentation, periodontal defect filling, root resection/apicocectomy/cystectomy defect filling, extraction socket filling for ridge preservation, maxillary sinus floor elevation, or peri-implant defect filling, including use 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

• OsteoGuide™ Anorganic Bone Mineral Products (K043034)

Submission Summary (Full Text)

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K07-2397

2007

#### 510(k) Summary of Safety and Effectiveness

| Applicant Name and Address: | Collagen Matrix, Inc.<br>509 Commerce Street<br>Franklin Lakes, New Jersey 07417 | OCT 1 8 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Peggy Hansen, RAC<br>Sr. Director, Clinical, Regulatory, and QA<br>Tel: [phone]<br>Fax: [phone] | |
| Date of Summary: | August 24, 2007 | |
| Device Common Name: | Bone Grafting Material | |
| Device Trade Name: | SynOss™ Synthetic Bone Graft Material | |
| Device Classification Name: | Bone Grafting Material, Synthetic<br>872.3930<br>LYC<br>Class II | |
| Predicate Device(s): | OsteoGuide™ Anorganic Bone Mineral Products<br>K043034 | |

### Description of the Device

SynOss™ Synthetic Bone Graft Material is an osteoconductive calcium phosphate based bone graft material with an apatite structure similar to that of human bone. The product is supplied in granular form, and it is sterile, non-pyrogenic, and for single use only.

#### Intended Use

SynOss Synthetic Bone Graft Material 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

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Collagen Matrix, Inc. 510(k) Summary of Safety and Effectiveness SynOss™ Synthetic Bone Graft Material

# Summary/Comparison of Technical Characteristics

SynOss Synthetic Bone Graft Material and its predicate have the same technological characteristics. In particular, the both SynOss and its predicate are the same with respect to intended use, material structure, material characterization, form, and sizes.

# Safety

SynOss Synthetic Bone Graft Material has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

### Effectiveness

The characteristics of the SynOss Synthetic Bone Graft Material meet the design requirements for an effective bone grafting material.

## Conclusion

The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, show that the SynOss Synthetic Bone Graft Material is safe and substantially equivalent to OsteoGuide Anorganic Bone Mineral Granules.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2007

Ms. Peggy Hansen Senior Director, Clinical, Regulatory, and Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K072397

Trade/Device Name: SynOss™ Synthetic Bone Graft Material Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 24, 2007 Received: August 27, 2007

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 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 yours,

Sautie y. Michino mD.

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

Device Name: SynOss™ Synthetic Bone Graft Material

Indications for Use:

SynOss Synthetic Bone Graft Material 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, apicocectorny, and cystectorny ●
- 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)

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"sion of Anesthesiology, General Hospital, Imaginon Control, Dental Devices

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