PARALLAX ACRYLIC RESIN WITH TRACERS TA

K050864 · Arthrocare Corp. · NDN · Jun 17, 2005 · Orthopedic

Device Facts

• Record ID: K050864
• Device Name: PARALLAX ACRYLIC RESIN WITH TRACERS TA
• Applicant: Arthrocare Corp.
• Product Code: NDN · Orthopedic
• Decision Date: Jun 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Parallax® Acrylic Resin with TRACERS® Ta 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).

Device Story

Parallax Acrylic Resin with TRACERS Ta is an opacified polymethylmethacrylate (PMMA) bone cement. It is used by physicians during vertebroplasty or kyphoplasty procedures to stabilize pathological vertebral body fractures. The device functions as a structural filler to provide fixation for fractures resulting from osteoporosis or lesions. The inclusion of Tantalum (Ta) as an opacifier allows for visualization under imaging during the procedure. The device is intended for prescription use in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polymethylmethacrylate (PMMA) bone cement; opacified with Tantalum (Ta). Class II device per 21 CFR 888.3027. Product codes: NDN, LOD.

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

• Parallax® Acrylic Resin with TRACERS* (K042947)

Submission Summary (Full Text)

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K050864

## 510(k) Summary

# ArthroCare Corporation Parallax® Acrylic Resin Kit with TRACERS* Ta Bone Cement Opacifier

## General Information

| Submitter Name/Address: | ArthroCare Corporation<br>680 Vaqueros Avenue<br>Sunnyvale, CA 94085-3523 |
|------------------------------------|---------------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng<br>Director, Regulatory Affairs |
| Date Prepared: | April 4, 2005 |
| Device Description | |
| Trade Name: | Parallax ' Acrylic Resin with TRACERS" Ta |
| Classification Name: | Bone Cement (21 CFR 888.3027) |
| Device Classification: | Class II<br>Panel: Orthopedic Devices |

#### Predicate Devices

Parallax® Acrylic Resin with TRACERS* K042947

### Product Description

Parallax Acrylic Resin with TRACERS Ta is an opacified polymethylmethacrylate (PMMA) bone coment.

### Intended Uses

Parallax Acrylic Resin with TRACERS Ta 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).

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# Substantial Equivalence

Substantial Equivalence
This Special 510(k) proposes a material modification for the Parallax Acrylic Resin with This Special 510(k) proposes a materard in K042947 on December 27, 2004. The TKACERS, which was previously endaled in the secure and sterilization mulcations for use, technology princesses with TRACERS remain the same as in the predicate cleared 510(k).

# Summary of Safety and Effectiveness

Summal y of Safety and Enectricals:3
The modified Parallax Acrylic Resin with TRACERS, as described in this Special 510(k), The modified I aranax Neryne Researce device. The proposed modification in material is not a substantial change or modification, and docs not significantly affect the safety or efficacy of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUN 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-3523

Re: K050864

Trade/Device Name: Parallax® Acrylic Resin with TRACERS® TA Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN,LOD Dated: April 4, 2005 Received: April 5, 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 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/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D.

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

510(k) Number (if known): K 250 86 4

Device Name: Parallax " Acrylic Resin with TRACERS" Ta

Indications for Usc:

Parallax * Acrylic Resin with TRACERS® Ta 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, myleoma).

Prescription Use X Over-the-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Hupd Rlurlio

(Division Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________