OSTEOPAL V

K050085 · Heraeus Kulzer,GmbH · LOD · Sep 14, 2005 · Orthopedic

Device Facts

• Record ID: K050085
• Device Name: OSTEOPAL V
• Applicant: Heraeus Kulzer,GmbH
• Product Code: LOD · Orthopedic
• Decision Date: Sep 14, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSTEOPAL® V bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

Device Story

Osteopal® V is an acrylic PMMA bone cement used in vertebroplasty and balloon kyphoplasty procedures. The device consists of powder and liquid components that undergo exothermic polymerization to form a hardened cement. It is intended for use by physicians in clinical settings to stabilize vertebral fractures. The device provides structural support to the vertebral body. Compared to the predicate, Osteopal® V features increased zirconium dioxide content for enhanced radiopacity and lower viscosity to facilitate delivery during surgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and chemical composition comparison to the predicate device.

Technological Characteristics

Acrylic PMMA bone cement; exothermic polymerization; contains zirconium dioxide as a radiopaque agent; lower viscosity formulation compared to predicate; supplied as powder and liquid components.

Indications for Use

Indicated for patients with pathological vertebral body fractures caused by osteoporosis, cancer, or benign lesions requiring vertebroplasty or balloon kyphoplasty.

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

• OSTEOPAL (K030903)
• PMA P810020

Submission Summary (Full Text)

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## Abbreviated 510(k)

Osteopal® V

SEP 1 4 2005

## 510(k) Summary

| | Jan 7th, 2005 | |
|------------------------------------------------|------------------------------------------------------|--|
| Date of summary | OSTEOPAL® V | |
| Device trade name | | |
| Common Name | PMMA Bone Cement | |
| Classification name | Bone Cement, 888.3027 | |
| Identification of the marketed device to which | OSTEOPAL® K030903 | |
| equivalence is claimed | PMA P810020 1998 | |
| Description of the device | Osteopal® V is an acrylic cement for use in | |
| | vertebroplasty and kyphoplasty. It is formed from | |
| | powder and liquid by exothermic polymerization. | |
| Intended use | OSTEOPAL® V bone cement is indicated for the | |
| | treatment of pathological fractures of the vertebral | |
| | body due to osteoporosis, cancer, or benign lesions | |
| | using a vertebroplasty or balloon kyphoplasty | |
| | procedure. | |
| Comparison of technological characteristics | Osteopal® V contains exactly the same chemical | |
| | components as Osteopal®. The only difference is | |
| | the significantly higher content of zirconium | |
| | dioxide in Osteopal® V for better X-ray contrast, | |
| | combined with a lower viscosity. | |
| Submitted by | Dr. Christian Tuchscherer | |
| | [phone]<br>phone: | |
| | [phone]<br>fax: | |
| | [e-mail] | |
| | | |
| | | |
| | | |
| | 7.92005 | |
| | Date | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS emblem, which consists of a stylized caduceus with three snakes intertwined around a staff. The emblem is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

SEP 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Christian Tuchscherer Heraeus Kulzer GmbH Division Heraeus Medical Philipp-Reis-StraBe 8/13 D-61273 Wehrheim / Ts. Germany

Re: K050085 Trade/Device Name: OSTEOPAL® V Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD, NDN Dated: August 24, 2005 Received: August 31, 2005

Dear Dr. Tuchscherer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave actemined ly marketed predicate devices marketed in interstate for use stated in the encrosury to regars actuated date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the exactions of the Federal Food, Drug, devices may been rochisomed in quire approval of a premarket approval application (PMA). and Costience recry that the device, subject to the general controls provisions of the Act. The 1 ou may, merclore, market are act include requirements for annual registration, listing of gencial controls profile of tactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is elabilited (650 and 2) trols. Existing major regulations affecting your device it may or subject to bash as Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Ovaouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advised that I Drivesan that your device complies with other requirements of the Act that I Dr Has Intactions and regulations administered by other Federal agencies. You must or any I cated butther and equirements, including, but not limited to: registration and listing (21 Comply with an the Fee orequirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It 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 – Dr. Christian Tuchscherer

This letter will allow you to begin marketing your device as described in your Section 510(k)
The start of the support of any for heat at the smiralence of your device to a l This letter will allow you to begin makemig your avias of your device of your device to a legally
premarket notification. The FDA finding of substantial end the permits vour premarket notification. The FDA miding of substantal organt of the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation and 18, 276, 0100 - Alge masses note the regulation entit If you desire specific advice for your device of varian and the regulation entitled,
contact the Office of Compliance at [phone] . . 4 007-07) . . You may obtain contact the Office of Compliance at (240) 270 - 1240 - 1 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You "Misbranding by reference to premarkst nothleation" (1) on the Division of Small
other general information on your responsibilities under the Act from the 1800 638-200 other general information on your responsionner and a tits toll-free number [phone] or Manufacturers, International and Consumer Pissionalites aroved thindustry/support/index.html.

Sincerely yours,

signature

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

510(k) Number (if known):

Device Name: OSTEOPAL® V

Indications For Use:

OSTEOPAL® V bone cement is indicated for the treatment of pathological fractures of OSTEOPAL vi bothe cellient is indiodrou for the treather.
the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

Prescription Use yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use no (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K050086 |
|---------------|---------|
|---------------|---------|

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