MODIFICATION TO SPACE CPSXL BONE CEMENT

K072496 · Dfine, Inc. · NDN · Oct 5, 2007 · Orthopedic

Device Facts

• Record ID: K072496
• Device Name: MODIFICATION TO SPACE CPSXL BONE CEMENT
• Applicant: Dfine, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPACE CpsXL bone cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures mav result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Story

SPACE CpsXL bone cement is a self-curing, two-component PMMA bone cement system used in vertebroplasty or kyphoplasty procedures. The system consists of a powder component (PMMA polymer, barium sulphate radiopacifier, benzoyl peroxide initiator) and a liquid component (methylmethacrylate monomer, hydroquinone stabilizer, N,N-dimethyl-p-toluidine promoter). The device is intended for use by physicians in clinical settings to stabilize vertebral fractures. By injecting the cement into the vertebral body, the device provides structural support, potentially reducing pain and restoring vertebral integrity in patients with fractures caused by osteoporosis or lesions. The cement cures in situ to form a solid filler.

Clinical Evidence

Bench testing only. Physical, chemical, and mechanical testing conducted to demonstrate performance and substantial equivalence to the predicate device.

Technological Characteristics

Self-curing PMMA bone cement. Two-component system: powder (PMMA polymer, barium sulphate, benzoyl peroxide) and liquid (methylmethacrylate monomer, hydroquinone, N,N-dimethyl-p-toluidine).

Indications for Use

Indicated for treatment of pathological vertebral fractures via vertebroplasty or kyphoplasty. Patient population includes individuals with painful vertebral compression fractures secondary to osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, 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

• SPACE CpsXL bone cement (K061531)

Submission Summary (Full Text)

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DFine Inc. 3047 Orchard Parkway San Jose, California 95134

# Premarket Notification [510(K)] Summary (per 21 CFR 807.92)

510(k) number

#### 1. Submitted by:

DFine, Inc. 3047 Orchard Parkway San Jose, CA 95134

| Contact Person: | Robert D. Poser, DVM |
|-----------------|------------------------------------------------|
| | Vice-President, Scientific and Medical Affairs |
| Telephone: | 408-321-9999 ext 224 |
| Facsimile: | 408-321-9403 |

Date Prepared: 31 August 2007

## 2. Device Name

| Trade/Proprietary Name | SPACE CpsXL bone cement |
|------------------------|--------------------------------|
| Common/Usual Name | Bone cement for Vertebroplasty |
| Classification Name | Filler, Bone cement |

## 3. Predicate Device:

The SPACE CpsXL bone cement is substantially equivalent to other bone cements intended for vertebroplasty, including SPACE CpsXL. bone cement, cleared under 510(k) K061531 by DFine, Inc. San Jose, CA.

#### 4. Intended use of the device

The SPACE CpsXL bone cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures mav result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

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# 5. Description of the Device

The SPACE CpsXL bone cement is a self-curing polymethyl-methacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure.

SPACE CpsXL bone cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N.N-dimethyl-p-toluidine as a promoter.

# 6. Summary of the technological characteristics of the device compared to the predicate device.

Documentation is provided which demonstrated the SPACE CpsXL bone cement to be substantially equivalent to other legally cleared devices. Both the SPACE CpsXL bone cement and the predicate are bone cements intended for use in vertebroplasty, and are similar with respect to chemical composition and fundamental scientific technology. Any differences do not significantly affect the safety and effectiveness of the device.

# 7. Testing

Physical, chemical and mechanical testing of the SPACE CpsXL bone cement has been conducted.

### 8. Conclusions

Based upon the testing and comparison to the predicate device and commercially available bone cements, the SPACE CpsXL bone cement, performs as intended and is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 * 2007

DFine, Inc. % Mr. Robert Poser Vice President, Scientific and Medical Affairs 3047 Orchard Parkway San Jose, CA 95134

Re: K072496

Trade/Device Name: SPACE CpsXL Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: September 1, 2007 Received: September 5, 2007

Dear Mr. Poser:

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

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Page 2 - Mr. Robert Poser

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Ruelup

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

Enclosure

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# Statement of Indications for Use

510(k) Number (if known):

Device Name: SPACE CpsXL bone cement

Indications for Use:

The SPACE CpsXL bone cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma) and malignant lesions (metastatic cancers, myeloma).

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

A510(k) N

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)

Barbara Kniepp

Division of General, Restorative. and Neurological Devices

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DFine, Inc.

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