CONFIDENCE HIGH VISCOSITY BONE CEMENT

K060300 · Disc-O-Tech Medical Technologies, Ltd. · NDN · Jun 21, 2006 · Orthopedic

Device Facts

• Record ID: K060300
• Device Name: CONFIDENCE HIGH VISCOSITY BONE CEMENT
• Applicant: Disc-O-Tech Medical Technologies, Ltd.
• Product Code: NDN · Orthopedic
• Decision Date: Jun 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

Device Story

Confidence High Viscosity Bone Cement is a radiopaque, self-curing PMMA bone cement; provided as a two-component system (20g polymer powder, 9.2g monomer liquid). Components are mixed manually by clinician prior to use. Used in vertebroplasty or kyphoplasty procedures to stabilize vertebral fractures. Radiopacity provided by 30.07% barium sulfate in powder. Device functions as a structural filler to provide mechanical fixation of fractured bone. Used in clinical/surgical settings by physicians. Benefits include stabilization of painful fractures and restoration of vertebral body integrity.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and comparison of material properties and chemical composition to predicate devices.

Technological Characteristics

Radiopaque, self-curing PMMA bone cement. Two-component system: 20g polymer powder, 9.2g monomer liquid. Contains 30.07% barium sulfate for radiopacity. High viscosity formulation. Sterile.

Indications for Use

Indicated for fixation of pathological vertebral body fractures via vertebroplasty or kyphoplasty. Patient population includes individuals with painful vertebral compression fractures due to osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancer, myeloma).

Regulatory Classification

Identification

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Predicate Devices

• Kyphon Inc.'s KyphX® HV-RTM Bone Cement (K041584)
• Stryker Corp.'s Spineplex Radiopaque Bone Cement (K032945)
• Cook Inc.'s Vertefix Radiopaque Bone Cement (K042691)

Submission Summary (Full Text)

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JUN 2 1 2006

# 510(K) Summary

Disc-O-Tech Medical Technologies Ltd. ¿ Confidence High Viscosity Bone Cement

#### Applicant Name

Disc-O-Tech Medical Technologies Ltd.

11 Ha'l-loshlim St..

Herzeliya 46724, Israel

#### Contact Person

1. Hila Wachsler-Avrahami

Disc-O-Tech Medical Technologies Ltd.

11 Ha'Hoshlim St., Herzeliya 46724, Israel

Tel: [phone], Fax: [phone]

2. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P 555 Thirteenth Street, NW, Washington, DC 20004 Tel: [phone]. Fax: [phone]

## Date Prepared

January 2006

# Trade/Proprietary Name

Confidence High Viscosity Bone Cement

# Common Name

PMMA Bone Cement

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K060300
Page 2 of 2

Disc-O-Tech Medical Technologies Ltd. Confidence High Viscosity Bone Cement 510(k)

## Classification Name

Filler, Bone Cement (For Vertebroplasty)

## Classification

Class II, per 21 CFR §888.3027

## Predicate Devices

- ✔ Kyphon Inc.'s KyphX® HV-RTM Bone Cement (K041584)
- V Stryker Corp.'s Spineplex "M Radiopaque Bone Cement (K032945)
- ✔ Cook Inc.'s Vertefix"M Radiopaque Bone Cement (K042691)

### Intended Use

The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

## System Description

The Confidence High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (20 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.

#### Substantial Equivalence

Based on the information provided in this premarket notification, the Confidence High Viscosity Bone Cement intended use. chemical composition, material properties, biocompatibility, principles of operation, technological characteristics, performance, and clinical application are substantially equivalent to those of the predicate devices.

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JUN 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disc-O-Tech Medical Technologies, Inc. c/o Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K060300

Trade/Device Name: Confidence High Viscosity Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Code: NDN Dated: May 19, 2006 Received: May 19, 2006

Dear Mr. Kahan:

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.

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

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Page 2 - Mr. Jonathan S. Kahan, Esq.

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" (21 CFR 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,

Hubert Humphrey

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(K) Number (if known):

Device Name: Confidence High Viscosity Bone Cement

Indication for Use:

The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ く (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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 JODE)

Hulut Lener us

Division of General, Restorative, and Neurological Devices

510(k) Number K060300