ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE

K071206 · Apatech , Ltd. · MQV · May 31, 2007 · Orthopedic

Device Facts

• Record ID: K071206
• Device Name: ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
• Applicant: Apatech , Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: May 31, 2007
• Decision: SESE
• Submission Type: Special
• 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 ABX E-Z-fil Putty is a synthetic, osteoconductive bone void filler; composed of phase-pure silicon-substituted hydroxylapatite scaffold within a resorbable polymer matrix. Device features interconnected, open porous structure mimicking human cancellous bone. Supplied as hydrated putty for manual application by surgeons; packed into bony voids or gaps during orthopedic procedures. Acts as a scaffold for bony infiltration; resorbs over time and is replaced by natural bone during healing. Used in clinical settings for orthopedic surgery; provides structural support for bone repair in non-load-bearing applications.

Clinical Evidence

Bench testing only. Testing confirmed the device meets requirements for calcium salt bone void fillers and provides a safe, effective scaffold for bone repair via bony infiltration.

Technological Characteristics

Phase-pure silicon-substituted hydroxylapatite scaffold; resorbable polymer matrix; hydrated putty form factor. Interconnected open porous structure. Osteoconductive. Non-electronic; no software or energy source.

Indications for Use

Indicated for patients requiring bone void filling in orthopaedic applications, including skeletal system gaps/voids in extremities, pelvis, and spine (including posterolateral fusion with hardware). Applicable to surgically created or traumatic osseous defects. Not for use in areas intrinsic to bony structure stability.

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

• Actifuse™ Bone Graft Substitute (K040082)

Submission Summary (Full Text)

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K071206

## Premarket Notification [510(K)] Summary (per 21 CFR 807.92)

MAY 3 1 2007

| Submitter: | ApaTech Limited<br>370 Centennial Avenue<br>Centennial Park<br>Elstree, Hertfordshire WD6 3TJ<br>United Kingdom |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Buckland PhD<br>[phone] (phone)<br>[phone] (fax) |
| Date Prepared: | 27 April 2007 |
| Classification: | Resorbable calcium salt bone void filler devices<br>have been classified by the Orthopedics Device<br>Panel as Class II Special Controls per 21 CFR<br>888.3045 |
| Trade Name: | Actifuse™ ABX E-Z-fil Putty Bone Graft<br>Substitute |
| Common Name: | Bone Void Filler |
| Predicate Devices: | Actifuse™ Bone Graft Substitute, K040082 |

#### 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™ ABX E-Z-fil Putty is phase-pure silicon-substituted hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the hydroxylapatite phase of Actifuse ABX E-Z-fil Putty is similar to human cancellous bone. Actifuse™ ABX E-Z-fill Putty is available as a hydrated putty.

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# Technological Characteristics and Substantial Equivalence

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

### Testing

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a simple, sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 1 2007

Apa Tech Limited % Ms. Candace Cederman Consultant 15058 Armel Drive Oregon City, Oregon 97045

Re: K071206

Trade/Device Name: Actifuse™ ABX E-Z-fil Putty Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: April 30, 2007 Received: May 1, 2007

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. 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 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. Candacc 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 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/industry/support/index.html.

Sincerely yo

Mark N. Malkerson

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):

Device Name: Actifuse™ ABX E-Z-fil Putty

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 × AND/OR (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)


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

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510(k) Number

63