ALLOGRAN-N-BONE VOID FILLER

K043514 · Biocomposites, Ltd. · MQV · Jan 21, 2005 · Orthopedic

Device Facts

• Record ID: K043514
• Device Name: ALLOGRAN-N-BONE VOID FILLER
• Applicant: Biocomposites, Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Jan 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Allogran-N™ is intended for use as a bone void filler or bone void substitute that are not intrinsic to the stability of the bony for bony voids or gaps structure. Allogran-N™ is to be packed into bony voids or gaps in the skeletal system (e.g., the spine, pelvis and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. Allogran-N™ is completely incorporated with new bone during the healing process.

Device Story

Allogran-N™ is a porous hydroxyapatite bone graft substitute provided as sterile granules. Intended for surgical implantation into non-structural bony voids or gaps in the spine, pelvis, or extremities. Upon direct contact with viable host bone, the material acts as a scaffold; new bone grows in apposition to the granule surfaces, filling pores during the healing process. The device is designed to be completely resorbed and incorporated into newly formed bone. Used by surgeons in clinical settings to fill osseous defects resulting from surgery or trauma. Benefits include providing a biocompatible osteoconductive matrix to facilitate natural bone regeneration.

Clinical Evidence

No formal clinical trial data provided. The manufacturer cites 6 years of regular clinical use with no reported adverse events concerning quality, safety, or effectiveness.

Technological Characteristics

Material: Porous hydroxyapatite. Form factor: Sterile granules. Principle: Osteoconductive bone void filler. Sterilization: Sterile for single patient use. No software or energy source.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (spine, pelvis, extremities) not intrinsic to structural stability. Defects may be surgically created or result from traumatic injury. No specific age or gender contraindications provided.

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

• ApatightTM-HA Bone Graft Substitute
• ApaPore® Bone Graft Substitute

Submission Summary (Full Text)

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

JAN 2 1 7005

K0435/V

# EXHIBIT VII

# 510(k) SUMMARY

### Allogran-N™

- Applicant Biocomposites Ltd Keele Science Park Keele Staffordshire England ST5 SNL

| Contact Person | J Stephen Bratt LL.B |
|----------------|-------------------------------|
| | Tel: [phone] |
| | Fax [phone] |
| | Email: [e-mail] |

| 1. | Classification Name: | Resorbable Calcium Salt Bone Void Filler Device |
|----|------------------------|-------------------------------------------------|
| | Common/Usual Name: | Bone Void Filler |
| | Trade/Proprietary Name | Allogran-N ^TM - Bone Void Filler |
| | Product Code | MQV |

#### Legally Marketed Predicate Devices

| | Common/Usual Name | Manufacturer |
|---|-------------------------------------|--------------|
| 1 | ApatightTM-HA Bone Graft Substitute | CERAbio LLC |
| 2 | ApaPore® Bone Graft Substitute | ApaTech Ltd |

#### Device Description

Allogran-N™ Bone Void Filler is a hydroxyapatite bone graft substitute for the repair of bony defects. The granules are provided sterile for single patient use. When the Allogran-N™ granules are placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. The product is completely incorporated into the newly formed bone.

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#### Intended Use / Indications

Allogran-N™ is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Allogran-N™ is packed into bony voids of the skeletal system (e.g., the spine, pelvis and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product is completely incorporated during the healing process. The Indications For Use statement is shown in Exhibit I.

### Summary of Technology

Allogran-N™ is composed of a porous calcium salt, hydroxyapatite, equivalent to that contained in the predicate devices and to that in routine clinical use. The technologies employed in Allogran-N™ and the predicate devices are therefore substantially equivalent. Allogran-N™ is presented in granules in the same manner as the predicate devices. The indications, contraindications, risks and potential adverse events are the same and thus substantially equivalent.

### Non Clinical Testing

Non clinical testing has been used to examine the chemical composition of Allogran-N™ which satisfies the standard for implantable hydroxyapatite.

### Clinical Testing

Allogran-N™ has been regularly used clinically for the past 6 years and no adverse events have been reported in that time concerning the quality, safety or effectiveness of Allogran-N™.

### Substantial Equivalence

Documentation provided demonstrates that Allogran-N™ is substantially equivalent to the legally marketed predicate devices in design, materials and indications. Allogran-N™ is well tolerated and completely incorporated into the defect site into which it is implanted and is safe and effective when used as indicated.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 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 extending from its head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JAN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen Bratt Managing Director Keele Science Park, Keele, Staffordshire, England ST5 5NL

Re: K043514 Trade/Device Name: Allogran-N™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Bone Void Filler Regulatory Class: II Product Code: MQV Dated: December 14, 2004 Received: December 20, 2004

Dear Mr. Bratt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the 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 encrosure) to regars) to regars and the Medical Device Amendments, or to conimeres prior to may 20, 2017 11:31 in accordance with the provisions of the Federal Food, Drug, de vices mat nave been receasined in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelove, mains of the Act include requirements for annual registration, listing of general controls provision 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 rice to such additional controls. Existing major regulations affecting your device can may or sate to are to deem 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 reaso be aar nove 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 or any 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 - Ms. Kacy Arnold, RN, MBA

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to ogen manieting your antial equivalence of your device to a legally prematicated 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 If you ucsife specific at 100 for Jour acchieves at [phone]. Also, please note the regulation entitled, Comation of Compulation in the market 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/industry/support/index.html

Sincerely yours,

O Mark A. Melhusen

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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### EXHIBIT I

### INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Allogran-N™

Indications For Use:

Allogran-N™ is intended for use as a bone void filler or bone void substitute that are not intrinsic to the stability of the bony for bony voids or gaps structure.

Allogran-N™ is to be packed into bony voids or gaps in the skeletal system (e.g., the spine, pelvis and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. Allogran-N™ is completely incorporated with new bone during the healing process.

Prescription Use メ (Part 21 CFR 801 Subpart D) Over-The-Counter use (Part 21 CFR 807 Subpart C)

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerson

(**Division Sign-Off**)
Division of General, Restorative,

110 1820

**510(k) Number** K043574

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