Parallax® Acrylic Resin Cartridge with TRACERS-Ta 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).

Device Description

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

AI/ML Overview

This 510(k) summary is for a medical device called "Parallax® Acrylic Resin Cartridge with TRACERS-Ta," which is a PMMA bone cement. The document establishes substantial equivalence to existing predicate devices (K050864 and K053180).

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

The document is a traditional 510(k) submission for a physical medical device (bone cement), focusing on:

Device Description: What the device is.
Intended Use: What the device is used for (fixation of pathological vertebral body fractures).
Substantial Equivalence: How it is similar to previously cleared devices.
Classification: Its regulatory classification.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI/MRMC studies. This type of information is typically found in submissions for AI/ML-driven devices, which this document is not.

Summary

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K060425

Image /page/0/Picture/1 description: The image shows the logo for ArthroCare Corporation. The logo consists of a stylized graphic to the left of the company name. The graphic is composed of several curved lines that converge to form a circular shape. The text "ArthroCare" is in a bold, sans-serif font, with "Corporation" in a smaller font size below it.

510(k) Summary

JUL 1 2 2006

ArthroCare Corporation Parallax® Acrylic Resin Cartridge with TRACERS-Ta

General Information
Manufacturer:	ArthroCare, Corporation680 Vaqueros AvenueSunnyvale, CA 94085
Establishment Registration Number:	2951580
Contact Person:	Valerie Defiesta-NgDirector, Regulatory Affairs
Date Prepared:	February 15, 2006

Device Description

Classification:	PMMA Bone Cement: Class II per 21 CFR888.3027
Trade Name:	Parallax ® Acrylic Resin Cartridge withTRACERS-Ta
Device Code:	NDN
Generic/Common Name:	Bone Cement

Predicate Device

Parallax ® Acrylic Resin with TRACERS ® -Ta	K050864
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Parallax® Acrylic Resin with TRACERS®-Ta

Parallax® Acrylic Resin Cartridge with TRACERS® K050864 K053180

Intended Use

Product Description

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

Substantial Equivalence

The subject device is substantially equivalent to the ArthroCare Parallax Acrylic Resin with TRACERS-Ta (K050864) and the Parallax Acrylic Resin Cartridge with TRACERS (K053180).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

Arthrocare Corporation, Inc. % Ms. Valerie Defiesta-Ng Director of Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523

Re: K060425

Trade/Device Name: Parallax Acrylic Resin Cartridge with Tracers - Ta Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: June 1, 2006 Received: June 2, 2006

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) I ma letter notification. The FDA finding of substantial equivalence of your device to a legally premaince noticate 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 in you attine office of Compliance at (240) 276-0120. 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Lemmercus
Mark N. Melkerson
Director

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):

Device Name:

Parallax® Acrylic Resin Cartridge with TRACERS-Ta

Indications for Use:

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

Concurrence of CDHH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	K060425	xii
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Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
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.(b)
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.”