CALLOS CMF BONE VOID FILLER

K042072 · Skeletal Kinetics, LLC · GXP · Sep 16, 2004 · Neurology

Device Facts

• Record ID: K042072
• Device Name: CALLOS CMF BONE VOID FILLER
• Applicant: Skeletal Kinetics, LLC
• Product Code: GXP · Neurology
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Callos CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². Callos CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeleton, including frontoorbital, malar, and mental areas.

Device Story

Callos CMF Bone Void Filler is an impactable, moldable, single-use, biocompatible calcium phosphate cement. It is used by surgeons to fill or repair neurosurgical burr holes, craniotomy cuts, and craniofacial defects, or to augment bony contours. The material is designed to remodel and be replaced by natural bone during the healing process. It is supplied in kit sizes of 3cc, 5cc, and 10cc. The device is applied directly to the defect site by the clinician to restore skeletal structure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Biocompatible calcium phosphate bone void filler; impactable and moldable consistency; single-use; supplied in 3cc, 5cc, and 10cc kits; designed for in-vivo remodeling and replacement by bone.

Indications for Use

Indicated for repair or filling of neurosurgical burr holes, craniofacial defects, and craniotomy cuts (≤25cm²) in patients requiring restoration or augmentation of craniofacial bony contours (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

• Callos Bone Void Filler (K030554)
• BoneSource HAC (Hydroxyapatite Cement) (K032366)
• Synthes Fast Set Putty (Norian CRS) (K012589)

Submission Summary (Full Text)

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

K642072

# 510(k) Summary

| General Information | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Skeletal Kinetics, LLC<br>10201 Bubb Road<br>Cupertino, CA 95014 |
| Establishment Registration Number: | 3003890476 |
| Contact Person: | Duran Yetkinler, M.D., Ph.D<br>Vice President Regulatory Affairs, and<br>Research and Design |
| Date Prepared: | July 29, 2004 |
| Device Description | |
| Classification Name: | Class II:84 GXP (21 CRF 882.5300) Methyl<br>Methacrylate for Cranioplasty; 79 IWP<br>(878.3550) Prosthesis, Chin, Internal<br>Panel: Neurosurgery |
| Trade Name: | Callos" CMF Bore Void Filler (subject to<br>change) |
| Generic/Common Name: | Hydroxyapatite Cement |
| Predicate Devices | |
| Callos Bone Void Filler | K030554 |

- 트 BoneSource HAC (Hydroxyapatite Cement) K032366 . Synthes Fast Set Putty (Norian CRS) K012589
# Intended Use

Callos CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². Callos CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeleton, including frontoorbital, malar, and mental areas.

# Product Description

Callos CMF Bone Void Filler is an impactable and moldable single use, biocompatible calcium phosphate bone void filler, that remodels and is replaced by bone during the healing process. Callos CMF is packaged in various kit sizes (3cc, 5cc, and 10cc).

# Substantial Equivalence

The subject and predicate devices are all classified as Methyl Methacrylate for Cranioplasty, and are intended for use in a variety of craniomaxillofacial applications. In

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

establishing substantial equivalence to the predicate devices, Skeletal Kinetics, LLC evaluated the indications for use, materials, technology, and product specifications. Completed performance testing and device comparison demonstrated that the subject device is substantially equivalent to the predicate devices, and is safe and effective for its intended use.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

SEP 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Duran Yetkinler, M.D., Ph.D. Vice President, Regulatory Affairs, and Research and Design Skeletal Kinetics 10201 Bubb Road Cupertino, California 95014

Re: K042072

Trade Name: Callos™ CMF Bone Void Filler Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: July 29, 2004 Received: August 06, 2004

Dear Dr. Yetkinler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass barea in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer of Prial) 2011-12-11 accordance with the provisions of the Federal Food, Drug, devices that hat t of 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. Tod may, dicrorols provisions of the Act include requirements for annual registration, listing of The general controls proving 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 1 toaso oo acribed 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 or any I 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 Of It Far 877) has may (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.

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

Page 2 - Duran Yetkinler, M.D., Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device of your device to a legally promatics notification: "The stars 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 If you dosire specific acres at [phone]. Also, please note the regulation entitled, Contact the Office of Coan to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Miriam C. Provost

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

Enclosure

{4}------------------------------------------------

# Indications Statement

Device Name: 510(k) Number: Callos™ CMF Bone Void Filler KO42072

Indications for use:

Callos CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and cranionomy cuts with a surface area no larger than 25cm². Callos CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniof acial skeleton, including fronto-orbital, malar, and mental areas.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---|
| 510(k)__________________________ | |
| Prescription Use<br>(Per 21 CFR 801.109) | X |

OR

| Over-the-Counter Use | __________________________ |
|----------------------|----------------------------|
|----------------------|----------------------------|

*Miriam C. Provost*

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

长042072 510(k) Number_

V