VERTAPLEX HV (SINGLE PACK AND DUAL PACK)

K091606 · Stryker Corp. · NDN · Oct 23, 2009 · Orthopedic

Device Facts

• Record ID: K091606
• Device Name: VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
• Applicant: Stryker Corp.
• Product Code: NDN · Orthopedic
• Decision Date: Oct 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vertaplex HV Radiopaque Bone Cement 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, myeloma).

Device Story

Vertaplex HV is a Polymethyl Methacrylate (PMMA) bone cement. It is injected directly into fractured vertebral bodies during vertebroplasty or kyphoplasty procedures to stabilize the fracture and relieve pain. The device is used in clinical settings by physicians. It functions as a structural filler to fix pathological fractures caused by conditions such as osteoporosis or lesions. The output is the hardened cement providing mechanical fixation of the vertebral body.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

PMMA bone cement. Radiopaque. Designed for injection into vertebral bodies. Chemical composition identical to predicate device.

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 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

• Stryker Vertaplex Radiopaque Bone Cement (K072118)

Submission Summary (Full Text)

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4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 269 324 5412 www.stryker.com

OCT 2 3 2009

## stryker

Instruments

## 510(k) Summary

| 510(k) Owner: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Becky E. Ditty<br>Regulatory Affairs Analyst |
| Registration No .: | 1811755 |
| Trade Name: | Stryker Vertaplex HV |
| Common Name: | PMMA Bone Cement |
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement |
| Regulation Number: | \$888.3027 |
| Predicate Device: | Stryker Vertaplex Radiopaque Bone Cement (K072118) |
| Device Description: | Vertaplex HV is Polymethyl Methacrylate cement used for the treatment of<br>painful vertebral fractures based on the predicate device Stryker Vertaplex<br>PMMA Radiopaque Bone Cement (Vertaplex). Vertaplex HV can be injected<br>directly into the fractured vertebral body by either Vertebroplasty or Kyphoplasty<br>procedures to relieve pain. |
| Indications for Use: | Vertaplex HV Radiopaque Bone Cement is indicated for the fixation of<br>pathological fractures of the vertebral body using vertebroplasty or kyphoplasty<br>procedures.<br>Painful vertebral compression fractures may result<br>from<br>osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic<br>cancers, myeloma). |
| Substantial Equivalence<br>(SE) Rational: | Stryker Vertaplex HV is composed of the same chemical components as Stryker<br>Vertaplex PPMA Bone Cement and is equivalent in performance. |
| Safety and Effectiveness: | Stryker Vertaplex HV is substantially equivalent in design, materials, intended<br>use and performance to the predicate device, Stryker Vertaplex PMMA Bone<br>Cement (K072118). Testing shows that the device meets similar performance<br>specifications as those for the predicate device. No new types of issues of<br>safety or effectiveness are introduced by using this device. |
| Submitted by: | Becky E. Ditty<br>Regulatory Affairs Analyst<br>Signature |
| Date Submitted: | June 1, 2009 |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Stryker Instruments % Ms. Becky E. Ditty Regulatory Affairs Analyst 4100 E. Milham Avenue Kalamazoo, MI 49001

## OCT 2 3 2009

Re: K091606

Trade/Device Name: Vertaplex HV Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, LOD Dated: October 6, 2009 Received: October 9, 2009

Dear Ms. Ditty:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Becky E. Ditty

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm111800 html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Allo, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 (1)53) Pred. 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 the [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark M. Milkusson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Vertaplex HV ____________________________________________________________________________________________________________________________________________________

## Indications for Use

Vertaplex HV Radiopaque Bone Cement 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, myeloma).

Prescription Use _ X (Part 21 CFR 801 Subpart D)

and/or

Over-The-Counter Use (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)

FOR M. MELKERSON

(Bivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091606