MEDTRONIC DENTAL TCP

K092087 · Medtronic Sofamor Danek USA, Inc. · LYC · Dec 30, 2009 · Dental

Device Facts

• Record ID: K092087
• Device Name: MEDTRONIC DENTAL TCP
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: LYC · Dental
• Decision Date: Dec 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Medtronic Dental TCP is indicated as a bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure of the oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Dental TCP provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. Medtronic Dental TCP is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects. Procedures include: Ridge augmentation . Sinus augmentation . Filling of cystic defects . Filling of extraction sites . Filling of lesions of periodontal origin . Craniofacial augmentation . . Filling of defects of endodontic origin . Mandibular reconstruction . Repair of traumatic defects of the alveolar ridge, excluding maxillary . and mandibular fracture . Filling of resection defects in benign bone tumors, benign cysts or . other osseous defects in the alveolar ridge wall . Medtronic Dental TCP may be used alone, or in combination with saline, blood, bone marrow aspirate or platelet rich plasma (PRP). . Medtronic Dental TCP may be mixed with autograft as a bone graft extender.

Device Story

Medtronic Dental TCP is a porous, resorbable, osteoconductive bone grafting material composed of medical grade beta-tricalcium phosphate. Supplied sterile for single-patient use, it serves as a scaffold for bony ingrowth, resorbing at a rate consistent with natural bone healing. Used by dental or oral/maxillofacial surgeons in clinical settings to fill bony voids or gaps not critical to structural stability. The material can be applied alone or mixed with saline, blood, bone marrow aspirate, platelet-rich plasma (PRP), or autograft (as a graft extender). By filling defects such as extraction sites or alveolar ridge deficiencies, it supports the patient's natural bone regeneration process.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material properties similar to legally marketed predicate devices.

Technological Characteristics

Material: Medical grade beta-tricalcium phosphate (beta-TCP). Form: Porous, resorbable granules. Function: Osteoconductive bone void filler. Sterilization: Supplied sterile. Connectivity: None (standalone material).

Indications for Use

Indicated for patients requiring bone void filling in the oral and maxillofacial region for surgically created or traumatic osseous defects. Used for ridge/sinus augmentation, cystic/extraction/lesion/resection defect filling, and mandibular reconstruction. Not for use in defects intrinsic to bony structure stability or maxillary/mandibular fractures.

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

• MASTERGRAFT® Resorbable Ceramic Granules (K082917)
• Synthes (USA) chronOS™- B-TCP (K053022)
• Cerasorb® Dental (K051443)

Submission Summary (Full Text)

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K092087

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# Medtronic Sofamor Dane Medtronic Dental TCP 510(k) Summary July 2009

DEC 3 0 2009

- l. Company: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis. TN 38132 Telephone: [phone] Fax: [phone]
Pamela Edwards Contact: Regulatory Affairs Specialist

- ll. Medtronic Dental TCP Proposed Proprietary Trade Name: Classification Name: Filler, bone void, calcium compound Product Code: LYC
### ���. Product Description/Purpose of Application

Regulation No .:

Medtronic Dental TCP is a porous, resorbable, osteoconductive bone grafting material made of medical grade ß-tricalcium phosphate. Medtronic Dental TCP is supplied sterile for single patient use. The device is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible.

872.3930

The purpose of this 510(k) application is to seek marketing clearance for Medtronic Dental TCP for use as a synthetic, resorbable bone void filler in the oral and maxillofacial region. Like the previously cleared predicates, MASTERGRAFT® Resorbable Ceramic Granules (K082917, SE 01/09/09), Synthes (USA) chronOS™- B-TCP (K053022, SE 01/23/06) and Cerasorb® Dental (K051443, SE 07/22/05), the subject system is intended as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. In addition, Medtronic Dental TCP can be mixed with autograft and used as a bone graft extender.

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2692087

#### Indications IV.

Medtronic Dental TCP is indicated as a bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure of the oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Medtronic Dental TCP provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

Medtronic Dental TCP is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects. Procedures include:

- . Ridge augmentation
- . Sinus augmentation
- Filling of cystic defects .
- Filling of extraction sites .
- Filling of lesions of periodontal origin .
- Craniofacial augmentation .
- . Filling of defects of endodontic origin
- Mandibular reconstruction .
- Repair of traumatic defects of the alveolar ridge, excluding maxillary . and mandibular fracture
- Filling of resection defects in benign bone tumors, benign cysts or . other osseous defects in the alveolar ridge wall

Medtronic Dental TCP may be used alone, or in combination with saline, blood, bone marrow aspirate or platelet rich plasma (PRP).

Medtronic Dental TCP may be mixed with autograft as a bone graft extender.

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K092087

### Substantial Equivalence V.

Documentation provided in this submission demonstrates that the subject device is substantially equivalent to the previously cleared devices including MASTERGRAFT® Resorbable Ceramic Granules (K082917, SE 01/09/09), Synthes (USA) chronOS™- β-TCP (K053022, SE 01/23/06) and Cerasorb® Dental (K051443, SE 07/22/05).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or a human figure with outstretched arms, composed of flowing lines. The symbol is positioned to the right of the text.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Pamela Edwards Regulatory Affairs Specialist Medtronic Sofamor Danek USA, Incorporated 1800 Pyramid Place Memphis, Tennessee 38132

DEC 30 2009

Re: K092087

Trade/Device Name: Medtronic Dental TCP Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material. _ . _ -Regulatory Class: II Product Code: LYC Dated: December 22, 2009 Received: December 23, 2009

Dear Ms. Edwards:

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 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. Edwards

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 (OS) 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.htm 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

hr
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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K09 2087

## 510(k) Number (if known):

Device Name: Medtronic Dental TCP

## Indications for Use:

Medtronic Dental TCP is indicated as a bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure of the oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Dental TCP provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

Medtronic Dental TCP is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects. Procedures include:

- Ridge augmentation .
- Sinus augmentation
- Filling of cystic defects
- Filling of extraction sites
- Filling of lesions of periodontal origin
- Craniofacial augmentation
- Filling of defects of endodontic origin
- Mandibular reconstruction
- Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
- Filling of resection defects in benign bone turnors, benign cysts or other osseous defects in the alveolar ridge wall

Medtronic Dental TCP may be used alone, or in combination with saline, blood, bone marrow aspirate or platelet rich plasma (PRP).

Medtronic Dental TCP may be mixed with autograft as a bone graft extender.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
Per 21 CFR 801.109 and and prescription use and over-the-counter use

Division of Anesthesiology. General Hospital Infection Control. Dental Devices

510(k) Number: K092087