PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003

K042947 · Arthrocare Corp. · NDN · Dec 27, 2004 · Orthopedic

Device Facts

• Record ID: K042947
• Device Name: PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
• Applicant: Arthrocare Corp.
• Product Code: NDN · Orthopedic
• Decision Date: Dec 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Parallax® Acrylic Resin with TRACERS® is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from ostcoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myleoma).

Device Story

Parallax® Acrylic Resin with TRACERS® is an opacified polymethylmethacrylate (PMMA) bone cement; used for stabilization of vertebral compression fractures during vertebroplasty or kyphoplasty procedures. Device is prepared and applied by physicians in clinical settings. Opacification allows for visualization during injection; provides structural fixation of fractured vertebral bodies. Benefits include pain relief and stabilization of fractures caused by osteoporosis or lesions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Polymethylmethacrylate (PMMA) bone cement; includes opacifier (TRACERS®) for radiopacity. Class II device (21 CFR 888.3027).

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

• Spineplex™ Radiopaque Bone Cement (K032945)

Submission Summary (Full Text)

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K042947

DEC 2 7 2004

ArthroCare Corporation Parallax® Acrylic Resin with TRACERS®

## 510(k) Summary of Safety and Effectiveness ArthroCare, Corporation Parallax® Acrylic Resin Kit with TRACERS® Bone Cement Opacifier

| General Information | |
|------------------------------------|--------------------------------------------------------------------|
| Manufacturer: | ArthroCare, Corporation<br>680 Vaqueros Ave<br>Sunnyvale, CA 94085 |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng<br>Director, Regulatory Affairs |
| Date Prepared: | October 25, 2004 |
| Device Description | |
| Classification Name: | Bone Cement (21 CFR 888.3027) |
| Trade Name: | Parallax ^® Acrylic Resin with TRACERS ^® |
| Generic/Common Name: | Bone Cement |
| Predicate Device | |

#### Predicate Device

Spineplex™ Radiopaque Bone Cement K032945

## Intended Use

Parallax® Acrylic Resin with TRACERS® is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from ostcoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myleoma).

## Product Description

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

## Substantial Equivalence

In establishing substantial equivalence to the predicate dcvice, ArthroCare compared the indications for use, materials, and mechanical properties of the subject device and the predicate device. Additionally, performance testing has been completed to demonstrate the substantial equivalence of the Parallax® Acrylic Resin with TRACERS® to the predicate device. The performance testing and device comparison demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Public Health Service

DEC 2 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Valerie Defiesta-Ng Arthrocare Corp. 680 Vaqueros Ave. Sunnyvale, California 94085

Re: K042947

Trade/Device Name: Parallax® Acrylic Resin with Tracers® Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: October 25, 2004 Received: October 26, 2004

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 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.

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Page 2 – Ms. Valerie Defiesta-Ng

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/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): __ lCO4 2947 Device Name: Indications for Use:

Parallax® Acrylic Resin with TRACERS® 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 cancers, myleoma).

Over-The-Counter Use Prescription Use 2 AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Miriam C. Provost

(Division Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________