APAPORE BONE GRAFT SUBSTITUTE

K033722 · Apatech , Ltd. · MQV · May 7, 2004 · Orthopedic

Device Facts

• Record ID: K033722
• Device Name: APAPORE BONE GRAFT SUBSTITUTE
• Applicant: Apatech , Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: May 7, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ApaPore® is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. ApaPore® is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect 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

ApaPore® is a synthetic, phase-pure hydroxylapatite bone void filler; functions as an osteoconductive scaffold. Device consists of irregularly shaped chips with interconnected, open porous structure mimicking human cancellous bone. Available in multiple sizes and porosities. Used by surgeons in clinical settings to fill non-structural bony gaps or voids resulting from surgery or trauma. Material is packed into the defect site; provides a scaffold for host bone infiltration and repair; resorbs over time as it is replaced by mature bone. Benefits include support for bone healing in non-load-bearing applications.

Clinical Evidence

Bench testing only. Device meets requirements for calcium salt bone void fillers. Clinical history of 16 months reported with no adverse events.

Technological Characteristics

Material: Phase-pure hydroxylapatite. Form: Irregular granules/chips. Structure: Interconnected, open porous scaffold. Energy source: None. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (extremities, spine, pelvis) where the void is not intrinsic to bony stability. Used as a scaffold for new host bone growth.

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

• Isotis NV OsSatura™ BCP Bone Void Filler (K030131)

Submission Summary (Full Text)

{0}------------------------------------------------

| MAY - 7 2004 | 510(k) Summary | K033722 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Submitter: | ApaTech Limited<br>Queen Mary<br>University of London<br>Mile End Road<br>London, United Kingdom<br>E1 4NS | |
| Contact Person: | Thomas Buckland Ph.D<br>[phone]/7690 (phone)<br>[phone] (fax) | |
| Date Prepared: | November 19th, 2003 | |
| Classification: | Resorbable calcium salt bone void filler<br>devices have been classified by the<br>Orthopedics Device Panel as Class II<br>Special Controls per 21 CFR 888.3045 | |
| Trade Name: | ApaPore® Bone Graft Substitute | |
| Common Name: | Synthetic, porous hydroxylapatite | |
| Predicate Devices: | Isotis NV OsSatura™ BCP Bone Void Filler<br>Isotis S.A.<br>K030131 - cleared May 20, 2003 | |

#### Intended use:

ApaPore® is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. ApaPore® is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect 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:

ApaPore® is phase-pure hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold. The interconnected and open porous structure of ApaPore® is similar to human cancellous bone. ApaPore® is available as irregularly shaped chips of 2 different sizes, in a choice of 3 porosities to suit surgeon preference.

{1}------------------------------------------------

## Technological Characteristics and Substantial Equivalence

ApaPore® 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 ApaPore® and both of its predicate devices is therefore substantially equivalent. ApaPore® is presented in irregular granules or chips in the same manner as its predicate devices. Its indications, contraindications, risks and potential nd verse events are the same and thus substantial equivalence is claimed for the device.

### Testing

Extensive bench testing has shown ApaPore® to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive precision of an receant ApaPore® to be safe and effective in providing a scaffold for rapid bone repair via bonny infiltration of the porous scaffolds. ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported.

{2}------------------------------------------------

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 eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2004

Apatech Ltd. C/o Barry Sall, RAC Senior Regulatory Consultant Parexel 195 West Street Waltham, Massachusetts 02451-1163

Re: K033722

Trade/Device Name: ApaPore® Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: April 2, 2004 Received: April 2, 2004

Dear Mr. Sall:

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 complics 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.

{3}------------------------------------------------

Page 2 -- Barry Sall, RAC

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/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

Mark A. Millburn

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: ApaPore® Bone Graft Substitute

Indications for Use:

ApaPore® is used in open bone voids that may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ApaPore® is intended for use on bone voids/gaps that are not intrinsic to the stability of the bony structure of the skeletal system, i.e., in the extremities, spine and pelvis.

ApaPore® is intended to be carefully packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine or pelvis). Following placement in the bony void. the synthetic bone void filler ApaPore® provides a scaffold for new mature host bone growth.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

510/\ K033722