CEROS TCP GRANULES

K101426 · Mathys, Ltd. · LYC · Sep 15, 2010 · Dental

Device Facts

• Record ID: K101426
• Device Name: CEROS TCP GRANULES
• Applicant: Mathys, Ltd.
• Product Code: LYC · Dental
• Decision Date: Sep 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros® TCP Granules may, for example, be used for: · supplementing autogenous cancellous bone · supporting and stabilizing for guided bone regeneration, "GBR" · filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy · filling bone defects resulting from traumatic or pathological origin · augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique) · filling defects after explantation of dental implants · filling small periodontal bone cavities as well as bi- and tri-furcations of teeth · the reconstruction of alveolar defects prior to providing a prosthesis · preparation of the implant bed (e.g. sinus lift) · filling bone defects around dental implant after immediate placement into extraction sockets Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.

Device Story

Synthetic, porous, osteoconductive, bioresorbable bone grafting material composed of beta-tricalcium phosphate (ß-TCP). Used in dental, oral, and maxillofacial surgery to fill, augment, or reconstruct bony defects. Clinician packs granules into surgical site; may be mixed with autogenous blood, bone marrow, or saline. Acts as scaffold for new bone growth; resorbs over time. Benefits patient by providing structural support for bone regeneration in non-loadbearing defects.

Clinical Evidence

Bench testing only. Testing included chemical composition (ICP, XRF), phase purity (quantitative XRD), trace element analysis (ICP/MS), particle size distribution (optical image analysis), surface morphology (SEM), and dissolution testing (ISO 10993-14).

Technological Characteristics

Synthetic beta-tricalcium phosphate (ß-TCP) granules. Conforms to ASTM F1088. Porous, osteoconductive, bioresorbable material. Provided in 0.5, 1.0, and 2.5 g volumes. Sterilized using standard methods.

Indications for Use

Indicated for patients requiring bone void filling in non-loadbearing oral and maxillofacial regions where cancellous bone is needed. Used for bone defects from trauma, pathology, tooth extraction, cystectomy, osteotomy, or tumor resection; alveolar reconstruction; sinus lifts; and dental implant site preparation.

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

• chronOS™ - B-TCP (K053022)
• Cerasorb® DENTAL (K051443)
• Cerasorb® M DENTAL (K051443)
• Calcium Hydroxylapatite Implant (K030682)

Submission Summary (Full Text)

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K101426 Ceros® TCP Granules

### 510(k) Summary

## Mathys Ltd Ceros® TCP Granules

September 9, 2010

#### ADMINISTRATIVE INFORMATION

SEP 1 5 2010

| Manufacturer Name: | Mathys Ltd |
|----------------------------|-------------------------------------|
| | Güterstrasse 5 |
| | CH-2544 Bettlach |
| | Switzerland |
| Telephone: | [phone] |
| Fax: | [phone] |
| Official Contact: | Giancarlo Rizzoli, PhD |
| | Director Business Unit Biosurgery |
| Email: | [e-mail] |
| Representative/Consultant: | Linda K. Schulz, RDH, BSDH |
| | Kevin A. Thomas, PhD |
| | PaxMed International, LLC |
| | 11234 El Camino Real, Suite 200 |
| | San Diego, CA 92130 |
| Telephone: | [phone] |
| Fax: | [phone] |
| email: | [e-mail] |
| | [e-mail] |

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: |
|-----------------------------|
| Common Name: |
| Classification Regulations: |
| Product Code: |
| Classification Panel: |
| Reviewing Branch: |

Ceros® TCP Granules Bone Grafting Material, Synthetic 21 CFR 872.3930 LYC Dental Products Panel Dental Devices Branch

#### INTENDED USE

Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros TCP Granules may, for example, be used for:

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#### 510(k) Summary

K101426

Ceros® TCP Granules

- · supplementing autogenous cancellous bone
- · supporting and stabilizing for guided bone regeneration, "GBR"
- · filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy
- · filling bone defects resulting from traumatic or pathological origin

· augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique)

- · filling defects after explantation of dental implants
- · filling small periodontal bone cavities as well as bi- and tri-furcations of teeth
- · the reconstruction of alveolar defects prior to providing a prosthesis
- · preparation of the implant bed (e.g. sinus lift)
- · filling bone defects around dental implant after immediate placement into extraction sockets

Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.

#### DEVICE DESCRIPTION

Ceros® TCP Granules are a synthetic, porous, osteoconductive, bioresorbable bone grafting material composed of beta-tricalcium phosphate, ß-TCP, [ß-C23]PO4]2] intended to fill, augment, or reconstruct bony defects in dental, oral or maxillofacial surgery. Ceros® TCP Granules are provided in volumes of 0.5, 1.0 and 2.5 g.

#### EQUIVALENCE TO MARKETED DEVICE

Mathys Ltd demonstrated that for the purposes of FDA's regulation of medical devices, Ceros TCP Granules are substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Synthes (USA) chronOS™ - B-TCP cleared under K053022,

Curasan AG Cerasorb® DENTAL and Cerasorb® M DENTAL cleared under K051443 BioForm, Inc., Calcium Hydroxylapatite Implant cleared under K030682.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject device is made of of B-TCP, [B-Ca3(PO4)2] conforming to ASTM F1088 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. Predicate devices are made of B-TCP or a similar material, CaHA, with similar particle size, pore size and porosity to the subject device. Subject and predicate devices are packaged in similar materials and sterilized using similar methods.

Bench testing was performed to demonstrate conformance to ASTM F1088, including chemical composition by inductively coupled plasma and x-ray fluorescence, ß-TCP content by quantitative x-ray diffraction, and trace element analysis by inductively coupled plasma/mass spectroscopy. Testing was also performed to characterize physical characteristics including particle size and particle size distribution by optical image analysis and surface morphology by scanning electron microscopy. Dissolution testing was performed according to ISO 10993-14.

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# 510(k) Summary

In summary, Ceros® TCP Granules have the following similarities to the predicate devices:

- . have the same intended use,
- . use the same operating principle,
- incorporate the same basic design, .
- incorporate the same or very similar materials, and .
- have similar packaging and is sterilized using the same materials and processes. .

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

#### Public Health Service

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

Mathys Limited C/O Ms. Linda Schulz PaxMed International LLC 11234 El Camino Real, Suite 200 San Diego, California 92130-8587

SEP 1 5 2010

Re: K101426

Trade/Device Name: Ceros® TCP Granules Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 16, 2010 Received: August 17, 2010

Dear Ms. Schulz:

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. Schulz

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 requireme
You must comply with all the Aot's resuire You must comply with all the Act's requirements, including, but not limited to: registration
and listing (21 CFR Part 807): lebeling (21 CER D . . (2002): and listing (21 CFR Part 807); labeling (21 CFR Part 801); mot limited to: regist
(reporting of medical device related education (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 (21 CFR Part 820)
the Act): 21 CFR 1000-1050 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 please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH) DRHOthees/ucm] 15809.htm for for for for for for 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/ReportalTroblem/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 Assis.
http://www.fda.org/Mali.clD http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hn 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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510(k) Summary

K101426
Ceros®TCP Granules

#### Indications for Use

510(k) Number: K101426

Device Name: Ceros® TCP Granules

SEP 1 5 2010

Indications for Use:

Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros® TCP Granules may, for example, be used for:

- · supplementing autogenous cancellous bone
· supporting and stabilizing for guided bone regeneration, "GBR"

· filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy

· filling bone defects resulting from traumatic or pathological origin

· augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique)

- · filling defects after explantation of dental implants
• filling small periodontal bone cavities as well as bi- and tri-furcations of teeth

- · the reconstruction of alveolar defects prior to providing a prosthesis
· preparation of the implant bed (e.g. sinus lift)

· filling bone defects around dental implant after immediate placement into extraction sockets

Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Turner

Page T of

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: حكومة الأمرات 2010)