SIMPLEX X

K032945 · Stryker Corp. · LOD · May 25, 2004 · Orthopedic

Device Facts

• Record ID: K032945
• Device Name: SIMPLEX X
• Applicant: Stryker Corp.
• Product Code: LOD · Orthopedic
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Spineplex™ 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

Stryker Spineplex™ Radiopaque Bone Cement is a PMMA-based bone cement used for the fixation of vertebral body fractures. It is intended for use in vertebroplasty or kyphoplasty procedures performed by clinicians. The device functions as a structural filler to stabilize fractures caused by osteoporosis or lesions. By providing mechanical fixation, it aims to reduce pain and restore vertebral stability. The formulation is modified from the predicate to provide increased working time and enhanced radiopacity for improved visualization during surgical placement.

Clinical Evidence

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

Technological Characteristics

PMMA (polymethyl methacrylate) bone cement. Modified ingredient ratios compared to predicate to optimize working time and radiopacity. Formulated for manual mixing and delivery during vertebroplasty/kyphoplasty procedures.

Indications for Use

Indicated for fixation of pathological vertebral body fractures via vertebroplasty or kyphoplasty. Patient population includes individuals with painful vertebral compression fractures secondary 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 Simplex® P

Submission Summary (Full Text)

{0}------------------------------------------------

K032945

striker INSTRUMENTS 2007 წლებში 2005 წლის 2001 წლის 2001 წლის 2001 წლის 2002 წლის 2002 წლის 2002 წლებში 2000 წელს 2000 წლებში 2000 წელს 2000 წლების 20

> 4100 Cast Milham Avenue
> Kalamazoo. MI 49001
> Phone [phone] [phone]

## 510(k) Summary

| Trade Name: | Stryker Spineplex™ Radiopaque Bone Cement |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | PMMA bone cement |
| Classification: | Bone Cement, 888.3027 |
| Equivalent to: | Stryker Simplex® P |
| Device Description: | Stryker Spineplex™ Radiopaque Bone Cement is a PMMA bone cement made of the same chemical components as Stryker Simplex® P. |
| Intended Use: | Spineplex™ 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). |
| Technological Comparison: | Stryker Spineplex™ Radiopaque Bone Cement is made of the exact components a Simplex™ P. The ratio of the ingredients has been modified to increase the working time and enhance visualization of the cement to meet customer needs in the fixation of vertebral compression fractures. |
| Submitted by: | Dannielle C. Wheeler<br>Sr. Regulatory Affairs Representative<br>Stryker Instruments |
| Signature | |
| Date | |
| Date Submitted: | Sept. 19, 2003 |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three wavy lines, representing health and medical services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 25 2004

Ms. Dannielle Wheeler Senior Regulatory Affairs Representative Stryker Corporation Instrument Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K032945

Trade/Device Name: Spineplex™ Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Codes: LOD, NDN Dated: February 27, 2004 Received: March 1, 2004

Dear Ms. Wheeler:

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.

{2}------------------------------------------------

Page 2 – Ms. Dannielle Wheeler

This letter will allow you to begin marketing your device as described in your Section 510(k) rms retect notification. The FDA finding of substantial equivalence of your device to a legally premailed 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. Milkeess

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

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known): K032945

Device Name: Spineplex™ Radiopaque Bone Cement

Indications for Use:

Spineplex™ 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 (Part 21 CFR 801 Subpart D)

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mark N. Millican

Division of General, Restorative, and Neurological Devices

KO32995 510(k) Number.

Page 1 of 1