ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES

K082575 · Apatech , Ltd. · MQV · Nov 25, 2008 · Orthopedic

Device Facts

• Record ID: K082575
• Device Name: ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
• Applicant: Apatech , Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Nov 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Story

Actifuse is a phase-pure, osteoconductive calcium phosphate bone void filler; incorporates 0.8wt% silicon into crystalline structure; features interconnected, open porous scaffold mimicking human cancellous bone. Available as granules or granules in resorbable polymer matrix. Used by surgeons in orthopedic procedures to fill non-structural bony voids/gaps; packed gently into defects. Acts as scaffold for bony infiltration; resorbs over time and is replaced by natural bone during healing. Provides structural support for bone repair; does not provide intrinsic stability to bony structure.

Clinical Evidence

Bench testing only. Testing confirmed device meets requirements for Calcium Salt Bone Void Fillers and provides a safe, effective scaffold for bony infiltration and repair.

Technological Characteristics

Phase-pure calcium phosphate scaffold; 0.8wt% silicon incorporated into crystalline structure; interconnected open porous architecture; available as granules or granules in resorbable polymer matrix.

Indications for Use

Indicated for patients requiring filling of non-structural bony voids or gaps in the skeletal system (extremities, pelvis, spine), including posterolateral fusion with stabilizing hardware. Applicable to 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.

Submission Summary (Full Text)

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K082575

# Premarket Notification [510(K)] Summary (per 21 CFR 807 92)

| Submitter: | ApaTech Limited<br>370 Centennial Avenue<br>Elstree, Hertfordshire WD6 3TJ<br>United Kingdom | NOV 25 2008 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | James J. Cassidy, Ph.D.<br>[phone] (phone)<br>[phone] (fax) | |
| Date Prepared: | 3 September 2008 | |
| Classification: | Resorbable calcium salt bone void filler devices have<br>been classified by the Orthopedics Device Panel as<br>Class II Special Controls per 21 CFR 888.3045,<br>Product Code MQV. | |
| Trade Name: | Actifuse™ Bone Graft Substitute<br>Actifuse™ Microgranules Bone Graft Substitute<br>Actifuse™ E-Z Prep<br>Actifuse™ ABX E-Z-fil Bone Graft Substitute<br>Actifuse™ MIS<br>Actifuse™ Shape Bone Graft Substitute | |
| Common Name: | Bone Void Filler | |

### Intended use:

Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

#### Device Description

Actifuse is a phase-pure calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse™ is similar to human cancellous bone.

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## Technological Characteristics and Substantial Equivalence

Actifuse™ is composed of a porous calcium salt equivalent to that contained in the predicate device and to that in routine clinical use. The technologies employed in Actifuse™ and its predicate device are therefore substantially equivalent. Actifuse™ has the same indications, contraindications, risks and potential adverse events as the predicate device and thus substantial equivalence is claimed for the device.

## Testing

Testing has shown Actifuse™ to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Testing has confirmed Actifuse™ to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold.

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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 and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a simple, vectorized design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2008

ApaTech, Ltd. % Ms. Candace F. Cederman 15058 Armel Drive Oregon City, Oregon 97045

Re: K082575

Trade/Device Name: Actifuse™ Bone Graft Substitute, Actifuse™ Microgranules Bone Graft Substitute, Actifuse "E-Z Prep. Actifuse" ABX E-Z fil Bone Graft Substitute, Actifuse™ MIS, Actifuse™ Shape Bone Graft Substitute

Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Codc: MQV Dated: September 3, 2008 Received: September 5, 2008

Dear Ms. Cederman:

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

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### Page 2 - Ms. Candace F. Cederman

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the from the Division of Small Manufacturers, International and Consumer Assistance at toll fire not more [phone]or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Milliman

- 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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### Statement of Indications for Use

510(k) Number (if known):

Device Name:

Actifuse™ Bone Graft Substitute Actifuse™ Microgranules Bone Graft Substitute Actifuse™ E-Z Prep Actifuse™ ABX E-Z-fil Bone Graft Substitute Actifuse™ MIS Actifuse™ Shape Bone Graft Substitute

#### Indications for Use:

Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

Mark A. Millerson

Division Sign-Off) Division of General, Restorative,

**510(k) Number**

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