OSSIFUSE BONE SUBSTITUTE MATERIAL

K072355 · Etex Corp. · MQV · Sep 26, 2007 · Orthopedic

Device Facts

• Record ID: K072355
• Device Name: OSSIFUSE BONE SUBSTITUTE MATERIAL
• Applicant: Etex Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OssiFuse 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. OssiFuse Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Story

OssiFuse is a synthetic, biocompatible bone graft substitute. It consists of a powder component and a mixing liquid, combined via a syringe-to-syringe system to form a paste. The paste is applied manually or via injection to bone voids or defects in the spine, pelvis, or extremities. Once implanted, the material hardens at body temperature, converting into poorly crystalline hydroxyapatite (PCHA), which mimics the mineral content of natural bone. The device is osteoconductive, meaning it is resorbed and replaced by natural bone over time. It is intended for use by surgeons in clinical settings to fill non-structural bone defects.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and chemical similarity to the predicate device.

Technological Characteristics

Synthetic, biocompatible, poorly crystalline hydroxyapatite (PCHA) bone graft substitute. Delivered as a paste via syringe-to-syringe mixing system. Hardens in situ at body temperature. Osteoconductive material.

Indications for Use

Indicated for filling bone voids or defects of the skeletal system (extremities, spine, pelvis) not intrinsic to bony stability. Applicable to surgically created or traumatic osseous defects. For prescription use.

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)

Submission Summary (Full Text)

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# ETEX Corporation Medical Device Special 510(k) Submission OssiFuse Bone Substitute Material

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

| Submitted By: | ETEX Corporation<br>38 Sidney Street, 3rd Floor<br>Cambridge, MA 02139 | SEP 26 2007 |
|-----------------|------------------------------------------------------------------------------|-------------|
| Contact Person: | Pamela W. Adams, R.A.C.<br>Senior Vice President and Chief Operating Officer | |

August 15, 2007 Date Prepared:

FDA Establishment Number:

1225112

- 2. Proprietary Name: OssiFuse Bone Substitute Material Common Name: Bone Void Filler Device Class: Class II Product Code: MQV
3. Legally Marketed Device for Substantial Equivalence Comparison: CaP3 Bone Substitute Material Product: Product Code: MQV Manufacturer: ETEX Corporation 510(k) #: K033138

## বঁ Comparison to the Predicate Device:

OssiFuse Bone Substitute Material is a synthetic bone substitute material that is similar to CaP3 Bone Substitute Material. OssiFuse and CaP3 have the same type and duration of patient contact, chemical composition, fundamental scientific technology and intended use. The handling characteristics are slightly different to enable delivery of the material through a needle. Once in the body, the material will perform in a similar manner due to the fact it is the same previously cleared material.

## 5. Device Description:

OssiFuse 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 OssiFuse powder component is combined with the mixing liquid and is mixed to form a paste. Mixing is facilitated by a syringe to syringe mixing system. The resulting paste can be administered to the treatment site by manual application or injection, and can be shaped in situ or into a desired

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# ETEX Corporation Medical Device Special 510(k) Submission OssiFuse Bone Substitute Material

form prior to implantation. After the paste is applied 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 the mineral content of natural bone, OssiFuse Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

#### 6. Indications for Use

OssiFuse Bone Substitute Material is 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. OssiFuse Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

#### 7. Substantial Equivalence

In summary, the OssiFuse Bone Substitute Material described in this submission is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Etex Corporation % Ms. Pamela W. Adams, RAC Senior Vice President & Chief Operating Officer 38 Sidney Street Cambridge, MA 02139

SEP 2 6 2007

Re: K072355

Trade/Device Name: OssiFuse Bone Substitute Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 21, 2007 Received: August 27, 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. Iisting 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. Pamela W. Adams

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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milliken

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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## ETEX Corporation Medical Device Special 510(k) Submission OssiFuse Bone Substitute Material

## INDICATIONS FOR USE STATEMENT

## ૨૫૦(K) Number (if known)

Device Name OssiFuse Bone Substitute Material

Indications for use OssiFuse 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. OssiFuse Bone Substitute Material 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 IF NEEDED

Concurrence of CDRH, Office of Device E

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

510(k) Number

Prescription Use

OR

Over-The Counter Use

(Per 21 CFR 801.109)