STRYKER INJECTABLE CEMENT

K060763 · Stryker · GXP · Sep 22, 2006 · Neurology

Device Facts

• Record ID: K060763
• Device Name: STRYKER INJECTABLE CEMENT
• Applicant: Stryker
• Product Code: GXP · Neurology
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial shelest of the

Device Story

Stryker® Injectable Cement is a self-setting calcium phosphate bone void filler. It is prepared and applied by surgeons in an operating room setting to fill cranial defects, burr holes, or skeletal voids. The cement is delivered into the defect where it cures in situ. It serves as a temporary filler to augment provisional hardware (e.g., plates, screws) by supporting bone fragments during the surgical procedure. It is not intended to provide long-term structural support. The device benefits patients by restoring bony contour and filling voids in the craniofacial skeleton and other skeletal sites.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-setting calcium phosphate cement. Formulated for in situ curing. Material properties consistent with previously cleared calcium phosphate bone cements. No electronic components or software.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities, craniofacial, spine, pelvis) caused by surgery or trauma. Indicated for non-structural voids not intrinsic to bony stability. Indicated for repair of neurosurgical burr holes, craniotomy cuts, and cranial defects. Not intended for structural support during healing.

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• Stryker® Injectable Cement (K060061)
• Stryker® HAC Rapid Set Cement (K043334)

Submission Summary (Full Text)

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K060763

# SEP 2 2 2006

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: Stryker® Injectable Cement

#### General Information

| Proprietary Name: | Stryker® Injectable Cement |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Hydroxyapatite Cement |
| Proposed Regulatory Class: | Class II |
| Device Classification: | GXP (21 CFR 882.5300) Methyl methacrylate for cranioplasty |
| Submitter: | Stryker®<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>877-534-2464 x 4226 |
| Submitter's Registration #: | 8010177 |
| Manufacturer's Registration #: | 9610726 |
| Contact Person: | Wade T. Rutkoskie<br>Manager, Regulatory Affairs and Quality Assurance<br>Phone: [phone] x 4226<br>Fax:<br>269-323-4215 |
| Summary Preparation Date: | January 4, 2006 |

### Intended Use

Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial shelest of the

## Substantial Equivalency Information

Stryker® Injectable Cement is substantially equivalent to legally marketed K060061 Stryker® Injectable Cement and K043334 Stryker® HAC Rapid Set Cement.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2006

Stryker % Mr. Wade Rutkoskie Manager RA/QA 750 Trade Centre Way, Suite 200 Portage, Michigan 49002

Re: K060763

Trade/Device Name: Stryker® Injectable Cement Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: GXP Dated: August 22, 2006 Received: August 23, 2006

Dear Mr. Rutkoskie:

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 - Mr. Wade Rutkoskie

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you've ough finding of substantial equivalence of your device to a legally premated notificated.
marketed predicated on 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 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 odio: Ecturers, International and Consumer Assistance at its toll-free-number (800)-633-2041 วr [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buechner

Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(K) Number (if known): K

## Device Name: Stryker® Injectable Cement

# Indications for Use:

Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, cramofacial; spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Stryker® Injectable Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary fragments during and is not intended to provide structural support during the healing process.

Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

Prescription Use (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)

Barbara Burchum

e of

(Posted November 13, 2003)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K060763