BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT

K991398 · Stryker Leibinger · GXP · Sep 22, 1999 · Neurology

Device Facts

• Record ID: K991398
• Device Name: BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
• Applicant: Stryker Leibinger
• Product Code: GXP · Neurology
• Decision Date: Sep 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area of 25 cm2 or less. BoneSource is also indicated for augmentation or restoration of bony contour in the craniofacial skeleton including the fronto-orbital, malar and mental areas.

Device Story

BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit consists of hydroxyapatite cement powder, a prefilled syringe of sodium phosphate solution, and a mixing spatula. Used by surgeons for cranial defect repair and craniofacial contour restoration. The cement is mixed intraoperatively and applied to the defect site, where it hardens to provide structural repair or augmentation. The expanded kit provides various sizes (5g to 50g) to accommodate different defect volumes. The device functions as a bone void filler/reconstructive material.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use similarities to predicate devices.

Technological Characteristics

Hydroxyapatite cement powder mixed with sodium phosphate solution. Supplied in kit form with prefilled syringe and mixing spatula. Sizes range from 5g to 50g. Material is a bone void filler/cement for cranial/craniofacial applications.

Indications for Use

Indicated for repair of neurosurgical burr holes, contiguous craniotomy cuts, and cranial defects (≤25 cm2) in patients requiring craniofacial skeletal augmentation or contour restoration (fronto-orbital, malar, mental areas).

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

• BoneSource Hydroxyapatite Cement (K953339)
• BoneSource Hydroxyapatite Cement (K864537)
• BoneSource Hydroxyapatite Cement (K970400)
• Norian® CRS™ Craniofacial Repair System (K973789)

Submission Summary (Full Text)

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K99/358

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS: BONESOURCE® Hydroxyapatite Cement (HAC) Expanded Kit

### General Information

| Proprietary Name: | BoneSource® Hydroxyapatite Cement (HAC)<br>Expanded Kit |
|--------------------------------|---------------------------------------------------------------------------------------------------------|
| Common Name: | Hydroxyapatite Cement (HAC) |
| Classification Name(s): | Prosthesis, Chin, Internal<br>Methyl Methacrylate for Cranioplasty |
| Classification Code(s): | 79FWP<br>87GXP |
| Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>800-253-7370 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 2183449 |
| Contact Person: | Kristyn R. Kelley<br>Project Engineer<br>Quality Assurance and Regulatory Affairs<br>800-253-7370 x5045 |
| Summary Preparation Date: | April 14, 1999 |

#### Predicate Device

The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is substantially equivalent to BoneSource Hydroxyapatite Cement (K953339, K864537 and K970400) and to Norian® CRS™ Craniofacial Repair System (K973789).

#### Device Description

The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit contains the previouslycleared BoneSource hydroxyapatite cement powder along with a new prefilled syringe containing sodium phosphate solution and a mixing spatula. Kits are being provided in sizes ranging from 5 g to 50 g.

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Public Health Service

SEP 2 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristyn R. Kelley Project Engineer Ouality Assurance and Regulatory Affairs Stryker®Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K991398

Trade Name: BoneSource Hydroxyapatite Cement (HAC) Regulatory Class: II Product Code: GXP, FWP Dated: July 19, 1999 Received: July 20, 1999

Dear Ms. Kelley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Kristyn R. Kelley

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices). please contact the Office of Compliance at [phone]. Furthermore, for questions regarding the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification (21 CFR 807.97)." Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

CaNo. M. Witton, Ph.D., M.D.

- Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 0 | 0<br>1<br>œ<br>11 | |
|---|-------------------|--|
| 1 | | |

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is indicated for use in the repair The Donesourgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface or nourcement but notes) e defect. BoneSource is also indicated for augmentation or arestoration of bony contour in the craniofacial skeleton including the fronto-orbital, malar and mental areas.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K991398 |

| Prescription Use<br>(Per 21 CFR 801.109) | Yes |
|------------------------------------------|-----|
|------------------------------------------|-----|

OR

| Over-The-Counter Use | No |
|----------------------|----|
|----------------------|----|

(Optional Format 1-2-96)