CAP PLUS

K063050 · Etex Corp. · MQV · Nov 19, 2007 · Orthopedic

Device Facts

• Record ID: K063050
• Device Name: CAP PLUS
• Applicant: Etex Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Nov 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CaP Plus is intended for use in filling bone voids or defects of the skeletal system (such as the extremities and the 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. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Story

CaP Plus is a biocompatible bone graft substitute; composed of synthetic calcium phosphate, inert carrier, carboxymethyl cellulose (CMC), and human demineralized bone matrix (DBM). Implanted into bone voids or defects; hardens at body temperature; resorbs and remodels into new bone during healing. DBM component assayed for osteoinductive potential in athymic nude mouse model. Used by surgeons in clinical settings to fill non-structural skeletal defects.

Clinical Evidence

No clinical data provided. DBM component osteoinductive potential assessed via athymic nude mouse model.

Technological Characteristics

Resorbable calcium salt bone void filler. Materials: synthetic calcium phosphate, carboxymethyl cellulose (CMC), human demineralized bone matrix (DBM). Hardens in situ at body temperature.

Indications for Use

Indicated for filling bone voids or defects of the skeletal system (extremities and pelvis) not intrinsic to bony stability, including surgically created or traumatic osseous defects.

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

• CaP3 Bone Substitute Material (K033138)
• Optium DBM™ Gel & Putty (K053098)
• ALLOMATRIX® Putty (K020895)
• InterGro® DBM (K031399)

Submission Summary (Full Text)

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## ETEX Corporation Medical Device 510(k) Submission CaP Plus CONFIDENTIAL

#### 510(k) SUMMARY AS REQUIRED UNDER 21 CFR 807.87(H) 8.

# SUMMARY OF SAFETY AND EFFECTIVENESS

| SPONSOR: | ETEX Corporation<br>University Park at MIT<br>38 Sidney Street, 3rd Floor<br>Cambridge, MA 02139<br>Phone: [phone]<br>Fax: [phone] | | NOV 1 9 2007 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|
| 510(k) CONTACT: | Pamela W. Adams, RAC<br>Senior Vice President and Chief Operating Officer | | |
| TRADE NAME: | CaP Plus | | |
| COMMON NAME: | Bone Void Filler<br>Bone Graft Material<br>Bone Substitute Material | | |
| CLASSIFICATION: | Class II | | |
| CLASSIFICATION NAME: | 21 CFR 888.3045<br>Resorbable Calcium Salt Bone Void Filler Device | | |
| PRODUCT CODE: | MQV | | |
| PREDICATE DEVICE(S): | CaP3 Bone Substitute Material (K033138)<br>Optium DBM™ Gel & Putty (K053098)<br>ALLOMATRIX® Putty (K020895)<br>InterGro® DBM (K031399) | | |

ETEX Corporation 510(k) CaP Plus Submission K063050

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### ETEX Corporation Medical Device 510(k) Submission CaP Plus CONFIDENTIAL

### Device Description:

CaP Plus is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, an inert carrier, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within the CaP Plus is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of CaP Plus osteoinductivity in humans.

#### Indications for Use:

Intended for use in filling bone voids or defects of the skeletal system (such as the extremities 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. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

### Basis of Substantial Equivalence:

CaP Plus shares the same function and intended use as the predicate devices. CaP Plus was found to be substantially equivalent to the predicate devices. The safety and effectiveness of CaP Plus is adequately supported by the substantial equivalence data and testing results provided within this premarket submission.

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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 features a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem, indicating the department's name and national affiliation. The logo is simple and recognizable, often used in official documents and communications related to health and human services in the United States.

NOV 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ETEX Corp % Ms. Pamala W. Adams Senior Vice President & Chief Operating Officer The Clark Bldg 38 Sidney Street, 3rd Floor Cambridge, MA 02139

Re: K063050

> Trade/Device Name: CaP Plus Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, MBP Dated: September 17, 2007 Received: September 24, 2007

Dear Ms Adams:

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 mav 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 -

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organization of substantial equivalence of your device to a legally prematics notineation. The Presults 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 desire specific and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to [phone]. This, process 100 and 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events Durveillance at (110) 270g (MDR)), please contact the Division of Surveillance Systems (Wedical Do Hopening (112 - 17)) For general information on your responsibilities under the at (210) 210 Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark Wilkerson

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) K063050

Device Name: CaP Plus

#### Indications for Use:

CaP Plus is intended for use in filling bone voids or defects of the skeletal system (such as the extremities and the 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. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR

Over-The Counter Use

(Per 21 CFR 801.109)

Barbara Breen for may

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

**510(k) Number** K063050