PORE-SI BONE GRAFT SUBSTITUTE

K040082 · Apatech , Ltd. · MQV · Aug 4, 2004 · Orthopedic

Device Facts

• Record ID: K040082
• Device Name: PORE-SI BONE GRAFT SUBSTITUTE
• Applicant: Apatech , Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 4, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pore-Si 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. Pore-Si 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

Pore-Si is a phase-pure, porous hydroxylapatite bone void filler. It acts as an osteoconductive scaffold, mimicking human cancellous bone structure to support bone repair. Supplied as irregular chips or granules, the device is packed manually by surgeons into non-structural skeletal voids or gaps in the extremities, spine, or pelvis. The material is resorbable, gradually replaced by natural bone during the healing process. It is intended for orthopedic surgical use.

Clinical Evidence

No clinical data. Evidence consists of extensive bench testing confirming compliance with standards for calcium salt bone void fillers and preclinical testing confirming safety and efficacy as an osteoconductive scaffold for bone repair.

Technological Characteristics

Material: Phase-pure hydroxylapatite. Structure: Interconnected, open porous scaffold mimicking cancellous bone. Form: Irregular chips/granules. Mechanism: Osteoconductive, resorbable bone void filler. Energy source: None (passive).

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities, spine, pelvis) that are not intrinsic to bony stability. Applicable to surgically created osseous defects or defects resulting from traumatic injury.

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

• OsSatura™ BCP Bone Void Filler (K030131)
• Skelite™ Synthetic Resorbable Bone Void Filler (K011726)

Submission Summary (Full Text)

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| | 510(k) Summary | K040082 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| AUG - 4 2004 | | |
| 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: | [Date] | |
| 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: | Pore-Si Bone Graft Substitute | |
| Common Name: | Synthetic, porous hydroxylapatite | |
| Predicate Devices: | Isotis NV OsSatura™ BCP Bone Void Filler<br>Isotis S.A. K030131 - cleared May 20, 2003<br>Skelite™ Synthetic Resorbable Bone Void<br>Filler (K011726), Millenium Biologix, Inc. - | |

## Intended use:

Pore-Si 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. Pore-Si 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:

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

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## Technological Characteristics and Substantial Equivalence

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

## Testing

Extensive bench testing has shown Pore-Si to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed Pore-Si to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffolds.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2004

ApaTech Limited C/o Mr. Barry Sall, RAC Senior Regulatory Consultant PAREXEL International 195 West Street Waltham, Massachusetts 02451-1163

Re: K040082

Trade Name: Pore-Si Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: July 14, 2004 Received: July 14, 2004

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren or (a) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered proc to they 20, 1978, as occordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dererere, mains 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 If your de rise 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 r lease be actives a adetermination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or uny I vith 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 - Mr. Barry Sall, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and no yourse FDA finding of substantial equivalence of your device to a legally prematics modicate 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 11 you attire 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 other general 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 yours,

Mark A. Willcox

Celia M. Witten, Ph.D., M.D. 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): _ KOG 0 0 82

Device Name: Pore-Si Bone Graft Substitute

Indications for Use:

Pore-Si 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. Pore-Si 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.

× Prescription Use_ (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Mark A. Milburn

1. Restorative. Division of Ge and Neurological Devices

510(k) Number K040082

Confidential