PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS

K053180 · Arthrocare Corp. · NDN · Jan 25, 2006 · Orthopedic

Device Facts

• Record ID: K053180
• Device Name: PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
• Applicant: Arthrocare Corp.
• Product Code: NDN · Orthopedic
• Decision Date: Jan 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Parallax® Acrylic Resin Cartridge with TRACERS is intended 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 cancers, mycloma).

Device Story

Parallax Acrylic Resin Cartridge with TRACERS is an opacified polymethylmethacrylate (PMMA) bone cement. Device is used by physicians during vertebroplasty or kyphoplasty procedures to stabilize vertebral body fractures. The cartridge delivery system facilitates the application of the cement into the vertebral body. The opacifying agent allows for visualization during the procedure. The device provides structural support to the fractured bone, aiming to reduce pain and restore vertebral integrity.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Opacified polymethylmethacrylate (PMMA) bone cement. Delivered via cartridge system. Class II device per 21 CFR 888.3027. Product code NDN.

Indications for Use

Indicated for fixation of pathological vertebral body 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

• Parallax® Acrylic Resin with TRACERS® (K042947)

Submission Summary (Full Text)

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## JAN 2 5 2006

# Parallax® Acrylic Resin Cartridge with TRACERS

510(k) Summary ArthroCare Corporation

| General Information | |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------|
| Manufacturer: | ArthroCare, Corporation<br>680 Vaqueros Avenue<br>Sunnyvale, CA 94085 |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng<br>Director, Regulatory Affairs |
| Date Prepared: | November 11, 2005 |
| Device Description | |
| Classification: | PMMA Bone Cement: Class II per 21 CFR<br>888.3027 |
| Trade Name: | Parallax ^® Acrylic Resin Cartridge With TRACERS |
| Device Code: | NDN |
| Generic/Common Name: | Bone Cement |
| Predicate Device | |
| Parallax ^® Acrylic Resin with TRACERS ^® : | K042947 |

#### Intended Use

Parallax® Acrylic Resin Cartridge with TRACERS is intended 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 cancers, mycloma).

#### Product Description

Parallax® Acrylic Resin Cartridge with TRACERS is an opacified polymethylmethacrylate bone cement.

#### Substantial Equivalence

The subject device is substantially equivalent to the ArthroCare Parallax Acrylic Resin with TRACERS (K042947).

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2006

Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthoCare Corp. 680 Vaqueros Ave. Sunnyvale, California 95408

Re: K053180

Trade/Device Name: Parallax Acrylic Resin Cartridge with Tracers Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: November 11, 2005 Received: November 14, 2005

Dear Ms. Defiesta-Ng:

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 - Ms. Valerie Defiesta-Ng

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,

Mark N. Melkerson

Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510(k) Number (if known):

KOS 3180

Device Name:

Parallax® Acrylic Resin Cartridge with TRACERS

Indications for Use:

Parallax® Acrylic Resin Cartridge with TRACERS is intended 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 cancers, myeloma).

Prescription Use (Part 21 CFR 801 Subpart D) X

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)

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(Division Sign-Off) (Division Sign of General, Restorative, Division rological Devices

510(k) Number_KOS3180