CAP3 BONE SUBSTITUTE MATERIAL

K033138 · Etex Corp. · MQV · Dec 2, 2003 · Orthopedic

Device Facts

• Record ID: K033138
• Device Name: CAP3 BONE SUBSTITUTE MATERIAL
• Applicant: Etex Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Dec 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CaP3™ Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CaP3™ Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Device Story

CaP3 is a synthetic, biocompatible bone graft substitute. At point-of-care, clinician mixes powder with 0.9% Sodium Chloride to form a paste. Paste is manually applied to bone voids or defects in extremities, spine, or pelvis; shaped in situ. Material hardens at body temperature, converting to poorly crystalline hydroxyapatite (PCHA). PCHA is osteoconductive; resorbed and replaced by natural bone during healing. Intended for non-structural defects.

Technological Characteristics

Synthetic, poorly crystalline hydroxyapatite (PCHA) bone graft substitute. Supplied as powder for mixing with 0.9% Sodium Chloride. Hardens in situ at body temperature. Osteoconductive. Sterile, single-use kit.

Indications for Use

Indicated for filling non-structural bone voids or defects in the skeletal system, including extremities, spine, and pelvis, resulting from surgery or traumatic injury in patients requiring bone graft substitutes.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• α-BSM® Bone Substitute Material (K011048)

Submission Summary (Full Text)

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

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

#### 510(k) SUMMARY AS REQUIRED UNDER 21 CFR 807.87(h) 7.

| SPONSOR: | ETEX Corporation |
|----------------------|-------------------------------------------------|
| | 38 Sidney Street, 3rd Floor |
| | Cambridge, MA 02139 |
| | Phone: [phone] |
| | Fax: [phone] |
| 510(k) CONTACT: | Duke Lee, Ph.D. |
| | Chief Scientific Officer |
| TRADE NAME: | CaP3™ Bone Substitute Material |
| COMMON NAME: | Bone Void Filler |
| | Bone Graft Material |
| | Bone Substitute Material |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | 21 CFR 888.3045 |
| | Resorbable Calcium Salt Bone Void Filler Device |
| PRODUCT CODE: | MQV |
| PREDICATE DEVICES: | α-BSM® Bone Substitute Material (K011048) |

# SUMMARY OF SAFETY AND EFFECTIVENESS

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

## DEVICE DESCRIPTION:

CaPy™ Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. It is intended for use in bone void filler applications in the spine, pelvis, and extremities. At the time of use, the CaP3™ product material is combined with the mixing liguid (U.S.P. Sodium Chloride, 0.9%), and is mixed to form a paste. The paste can be administered to the treatment site by manual application, and be shaped in situ or into a desired form prior to implantation. After applying the paste to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of natural bone. CaP3™ Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

### INDICATIONS FOR USE:

CaP3™ Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CaP3™ Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

CaP3™ Bone Substitute Material is a synthetic bone graft substitute material substantially equivalent to a-BSM® Bone Substitute Materials are provided sterile and as single patient, single use kits and are identical in intended use (i.e., bone void filler indications). CaP3™ Bone Substitute Material is also similar to a-BSM® Bone Substitute Material in material properties and in product performance characteristics. Differences between the CaP3™ and a-BSM® products do not raise any new questions of safety and effectiveness.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three wavy lines.

Public Health Service

DEC - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Duke Lee, Ph. D. Chief Scientific Officer ETEX Corporation University Park at MIT 38 Sidney Street Cambridge, MA 02139

Re: K033138

Trade Name: CaP3 Bone Substitute Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 26, 2003 Received: September 30, 2003

Dear Dr. Lee:

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

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

Page 2 - Duke Lee, Ph.D.

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), 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,

Sincerely, yours,

Mark N. Millikan

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}------------------------------------------------

510(k) Number (if known) K033138

Device Name: CaP3 Bone Substitute Material

#### Indications for Use:

CaP3 Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CaP3 Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Concurrence of CDRH, Office of Device Evaluation Prescription Use _ OR

(Per 21 CFR 801.109)

Over-The Counter Use

for Mark N Mikkelsen

citation facetorative

:.10(k) Number