KYPHX HV-R, MODEL C01A

K033801 · Kyphon, Inc. · NDN · Apr 1, 2004 · Orthopedic

Device Facts

• Record ID: K033801
• Device Name: KYPHX HV-R, MODEL C01A
• Applicant: Kyphon, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Apr 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KyphX® HV-R bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure.

Device Story

KyphX® HV-R bone cement is a two-component PMMA-based system (powder and liquid) used in kyphoplasty procedures. The powder contains PMMA copolymer, barium sulfate (radiopacifier), and benzoyl peroxide (initiator); the liquid contains methyl methacrylate monomer, hydroquinone (stabilizer), and N,N-dimethyl-p-toluidine (promoter). Components are mixed by the clinician prior to use. The cement is injected into the vertebral body to stabilize pathological fractures caused by osteoporosis. It provides structural support to the fractured bone. The device is intended for single use in a clinical setting.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including mechanical testing per ISO 5833:2002 and biocompatibility evaluation per ISO 10993.

Technological Characteristics

Two-component PMMA bone cement. Powder: PMMA/methyl-methacrylate-styrene copolymer, barium sulfate, benzoyl peroxide. Liquid: methyl methacrylate monomer, hydroquinone, N,N-dimethyl-p-toluidine. Mechanical properties verified per ISO 5833:2002. Biocompatibility per ISO 10993. Sterilization: Gamma radiation (solid components/pouch, SAL 10^-6), filtration (liquid, SAL 10^-3), and ethylene oxide (outer packaging).

Indications for Use

Indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis in patients undergoing a kyphoplasty procedure.

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

• Stryker Howmedica Surgical Simplex®P Radiopaque pre-packed in ACM and MixEvac II (K002652)
• Howmedica Osteonics Surgical Simplex®P Radiopaque Bone Cement (N017004)

Submission Summary (Full Text)

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## Tab 5

# Premarket Notification [510(k)] Summary

| Trade Name: | KyphX® HV-R bone cement | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Common Name: | Bone Cement | |
| Classification /Name: | Class II<br>Bone Cement: 21 CFR, part 888.3027 | |
| Device Code: | LOD | |
| Manufacturer's Name: | Kyphon Inc. | |
| Address: | 1350 Bordeaux Drive<br>Sunnyvale, CA 94089 | |
| Corresponding Official: | Richard W. Mott | |
| Title: | President and CEO | |
| Address: | 1350 Bordeaux Drive<br>Sunnyvale, CA 94089 | |
| Telephone: | 408-548-6500 | |
| Predicate Device(s): | K002652: | Stryker Howmedica Surgical Simplex®P<br>Radiopaque pre-packed in ACM and MixEvac II. |
| | N017004: | Howmedica Osteonics Surgical Simplex®P<br>Radiopaque Bone Cement |
| Intended Use: | The KyphX® HV-R bone cement is indicated for the<br>treatment of pathological fractures of the vertebral body<br>due to osteoporosis using a kyphoplasty procedure. | |

### CONFIDENTIAL

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product can be lawfully market without premarket approval or reclassification, and is not intended to be inferpreted as an admission or any other type of evidence in patent infringement litigation. The present submission is therefore not related to the coverage of any patent or whether these products or their uses may be considered distinct from a patent point of view.

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K033801 Page 2 of 3

Like the predicate device, KyphX® HV-R bonc coment is Device Description: provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl pcroxide as an initiator. The liquid component consists ી methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

> Table 5-1 compares the chemical composition of KyphX00 HV-R to the predicate device.

| Chemical Composition | KyphX® HV-R | Surgical Simplex® P |
|------------------------------------------------------------------------|--------------------------------|----------------------------------------------|
| Powder | 20 g. packet of sterile powder | 20 g (half-dose) packet of sterile<br>powder |
| Polymethyl methacrylate<br>/ methyl methacrylate-<br>styrene copolymer | 68.0% w/w | 88.5% w/w |
| Barium sulfate | 30.0% w/w | 10.0% w/w |
| Benzoyl peroxide | 2.0% w/w | 1.5% w/w |
| Liquid | 10 ml vial of sterile liquid | 10 ml (half-dose) vial of sterile<br>liquid |
| Methyl methacrylate<br>(monomer) | 99.1% v/v | 97.4% v/v |
| N, N-dimethyl-p-<br>toluidine | 0.90% v/v | 2.6% v/v |
| Hydroquinone | 75 ppm | 75 ± 15 ppm |

### Table 5-1: Chemical Composition of KyphX® HV-R and Surgical Simplex®P

Mechanical Tcsts:

KyphX® HV-R bone cement was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by ISO 5833:2002, "Implants for Surgery - Acrylic resin cements."

#### CONFIDENTIAL

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product can be lawfully marketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. The present submission is therefore not related to the coverage of any patent or whether these products or their uses may be considered distinct from a patent point of view.

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- Clinical information demonstrates that the intended use of Clinical Discussion: KyphX® HV-R is substantially equivalent to the predicate indication for the fixation of pathological fractures and does not adversely impact safety or effectiveness.
- Biocompatibility: The materials used in KyphX HV-R meet the requirements for "Implant, Tissue/Dentin/Bone, Permanent Contact" described in the FDA Blue Book Memorandum #G95-1. KyphX® HV-R bone cement was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by 1SO-10993. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
- The KyphX® HV-R bone cement is sterile and non-Sterilization: pyrogenic. The solid components and pouch are sterilized with gamma radiation to a Sterility Assurance Level (SAL) of 10°. The liquid components are sterilized with filtration methods to an SAL of 10-3. The outer packaging containing the liquid component is sterilized with ethylene oxide gas. The bone cement is intended for single use only.
- Substantial Equivalence: The information submitted in this pre-market notification supports a determination that KyphX® HV-R bone cement is substantially equivalent in technological characteristics and intended use to the predicate, Surgical Simplex®P. The products have the same fundamental scientific technology in their chemical composition, matcrial properties, performance characteristics, biocompatibility and clinical application.

### CONFIDENTIAL

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product can be lawfully marketed without premarket approval or reclassification, and is not intended to the interpreted as an admission or any other type of evidence in patent infringement litigation. The present submission is therefore not related to the coverage of any patent or whether these products or their uses may be considered distinct from a patent point of view.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 1 2004

Cindy Domecus Vice President, Clinical Research and Regulatory Affairs Kyphon, Inc. 1350 Bordeaux Drive Sunnyvale, California 94089

Re: K033801

Trade/Device Name: KyphX HV-R, Model C01A Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: February 24, 2004 Received: February 25, 2004

Dear Ms. Domecus:

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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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,
Mark A. Milkens

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

Enclosure

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Amendment to K033801 Revised Indications for Use March 30, 2004

# Indications for Use

510(k) Number (if known): K033801

Device Name: KyphX® HV-R Bone Cement

Indications for Use:

The KyphX® HV-R Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure.

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

Over-The-Counter Use (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

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510(k) Number K033801