OSSIPRO BONE SUBSTITUTE MATERIAL

K062630 · Etex Corp. · MQV · Jun 28, 2007 · Orthopedic

Device Facts

• Record ID: K062630
• Device Name: OSSIPRO BONE SUBSTITUTE MATERIAL
• Applicant: Etex Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Jun 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OssiPro Bone Substitute Material is an injectable, self setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, 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. OssiPro is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Story

OssiPro is an injectable, synthetic, biocompatible bone graft substitute. Material is mixed with a hydration solution to a smooth consistency and delivered to the bone defect site via syringe and needle/cannula. Upon delivery, the paste hardens at body temperature, forming a macro-porous, poorly crystalline hydroxyapatite (PCHA) scaffold. The device is used by surgeons in clinical settings to fill surgically created or traumatic osseous defects. It acts as an osteoconductive scaffold that resorbs over time, facilitating replacement with new natural bone. The device provides a structural filler that mimics the chemical identity and crystalline structure of natural bone.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Injectable, synthetic, biocompatible, resorbable calcium phosphate bone void filler. Converts to macro-porous, poorly crystalline hydroxyapatite (PCHA) scaffold in situ. Hardens at body temperature. Supplied as a powder to be mixed with a hydration solution.

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. For use in patients requiring bone graft substitutes that resorb and are replaced by new bone.

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)
• α-BSM® Bone Substitute Material (K011048)
• JAX™ Granules Bone Void Filler (K010557)

Submission Summary (Full Text)

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K062630

## ETEX Corporation Medical Device 510(k) Submission OssiPro Bone Substitute Material CONFIDENTIAL

JUN 2 8 2007

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

# SUMMARY OF SAFETY AND EFFECTIVENESS

| SPONSOR: | ETEX Corporation<br>University Park at MIT<br>38 Sydney Street, 3rd Floor<br>Cambridge, MA 02139<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Frances A. Florence<br>Regulatory Affairs Specialist |
| TRADE NAME: | OssiPro Bone Substitute Material |
| 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>α-BSM® Bone Substitute Material (K011048)<br>JAX™ Granules Bone Void Filler (K010557) |

理论 -

08/31/2006

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#### ETEX Corporation Medical Device 510(k) Submission OssiPro Bone Substitute Material CONFIDENTIAL

#### Device Description:

OssiPro Bone Substitute Material is an injectable synthetic, biocompatible bone graff substitute material. It is intended for use in bone void filler applications in the spine, pelvis, and extremities. At the time of use, OssiPro is combined with the hydration solution and is mixed to a smooth consistency. The material can be delivered to the defect site by injection with provided syringe or with desired needle/cannula (not provided). After delivering the paste to the treatment site, it forms pores while hardening at body temperature and converts to a macro-porous, poorly crystalline hvdroxvapatite (PCHA) scaffold. The end product has a similar chemical identity and crystalline structure to that of natural bone. OssiPro Bone Substitute Material is an osteoconductive bone graft substitute that resorbs and is replaced with new bone over time.

#### Indications for Use:

OssiPro Bone Substitute Material is intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, spine, 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. OssiPro is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

#### Basis of Substantial Equivalence:

OssiPro Bone Substitute Material has the same intended use and similar technological characteristics CaP3 Bone Substitute Material, α-BSM® Bone Substitute Material, and JAX™ Granules Bone Void Filler. Differences between OssiPro, CaP3, a-BSM8, and JAX™ products do not raise any new questions of safety and effectiveness. Thus, the OssiPro Bone Substitute Material is substantially equivalent to the predicate devices.

And Party

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 2 8 2007

ETEX Corporation % Ms. Frances A. Florence Regulatory Affairs Specialist University Park at MIT 38 Sidney Street, 3rd Floor Cambridge, Massachusetts 02139

Re: K062630

Trade Name: OssiPro 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: April 25, 2007 Received: April 26, 2007

Dear Ms. Florence:

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

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Page 2 - Ms. Frances A. Florence

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. 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 toll-free number [phone] or [phone] or at the Internet address http://www.fda.gov/odrh/industry/support/index.html

Sincerely yours,

FOR
Mark N. Melkerson
DEP V.R
6/27/07

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

Enclosure

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### ETEX Corporation Medical Device 510(k) Submission OssiPro Bone Substitute Material CONFIDENTIAL

510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

Device Name:

OssiPro Bone Substitute Material

#### Indications for Use:

OssiPro Bone Substitute Material is an injectable, self setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, 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. OssiPro is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

(Please Do Not Write Below This Line-Continue On Another Page As Needed)

Concurrence of CDRH, Office of Device Evaluation

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | 14062630 |
|---------------|----------|
|---------------|----------|

| Prescription Use | OR | Over-The Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

ETEX Corporation 510(k) OssiPro Bone Substitute Submission