FORMAGRAFT COLLAGEN BONE GRAFT MATRIX

K050789 · R and D Medical, LLC · MQV · May 27, 2005 · Orthopedic

Device Facts

• Record ID: K050789
• Device Name: FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
• Applicant: R and D Medical, LLC
• Product Code: MQV · Orthopedic
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Formagraft Collagen Bone Graft Matrix is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). 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 the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Formagraft is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Formagraft should not exceed 30 mL.

Device Story

Formagraft is a resorbable bone graft substitute composed of purified bovine fibrillar collagen and hydroxyapatite/beta-tricalcium phosphate (HA/B-TCP) ceramic. It functions as an osteoconductive scaffold for new bone growth. The device is supplied as a matrix to be packed into non-load-bearing bony voids or gaps in the extremities, spine, or pelvis. It may be mixed with autogenous bone marrow by a physician prior to implantation. In weight-bearing applications, it must be used with internal or external fixation. The material resorbs over time and is replaced by new bone. It is intended for use by surgeons in clinical settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material composition, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Materials: Purified bovine fibrillar collagen, hydroxyapatite (HA), and beta-tricalcium phosphate (B-TCP). Compliance: ASTM F1185 (HA), ASTM F1088 (B-TCP). Sterilization: Radiation (ANSI/AAMI/ISO 11137, AAMI TIR 27). Form factor: Matrix/scaffold. Energy source: None (passive implant).

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability. Applicable to surgically created or traumatic osseous defects. Contraindicated for use as a load-bearing device without internal or external fixation. Maximum defect size 30 mL.

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

• Healos Bone Graft Material (K012751)
• Collagraft Strip Bone Graft Matrix (K000122)
• Bi-Ostetic (K023703)
• Vitoss Scaffold Foam (K032288)

Submission Summary (Full Text)

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

### 510(k) Summary

# Formagraft" Collagen Bone Graft Matrix

Page 1 / 2

## ADMINISTRATIVE INFORMATION

| Manufacturer Name: | R and D Medical, LLC<br>1048 Irvine Avenue, Suite 354<br>Newport Beach, CA 92660 | MAY 2 7 2005 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Official Contact: | Kathleen Swantkoski<br>Telephone: [phone]<br>FAX: [phone] | |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International<br>4329 Graydon Road<br>San Diego, CA 92130<br>Telephone: [phone]<br>FAX: [phone]<br>e-mail: [e-mail] | |

### DEVICE NAME

| Classification Name: | Filler, calcium sulfate preformed pellets |
|-------------------------|-------------------------------------------|
| Trade/Proprietary Name: | FormagraftTM Collagen Bone Graft Matrix |
| Common Name: | Bone void filler |
| Product Code: | MQV |

## DEVICE CLASSIFICATION

Calcium sulfate preformed pellets have been classified by FDA as Class II, Special Controls, in a Final Rule effective July 2, 2003 (68 FR 32635) (21 CFR 888.3045). Calcium phosphate devices have been cleared as substantially equivalent to calcium sulfate devices.

#### CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards have been established under Section 514.

Voluntary standards with which Formagraft Collagen Bone Graft Matrix complies include ASTM F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants, ASTM F1088, Standard Specification for Composition of Beta-Tricalcium Phosphate for Surgical Implantation, ANSI/AAMI/ISO 11137 Sterilization of Health Care Products - Radiation Sterilization, and AAMI TIR 27 Sterilization of health care products-Radiation sterilization-Substantiation of 25 kGy as a sterilization dose-Method VD max-

A Special Control that applies to Formagraft Collagen Bone Graft Matrix is the FDA CDRH guidance document Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry & FDA, June 2, 2003.

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

### INTENDED USE

Formagraft Collagen Bone Graft Matrix is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). 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 the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Formagraft is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Formagraft should not exceed 30 mL.

## DEVICE DESCRIPTION

Formagraft is a bone graft substitute consisting of resorbable purified fibrillar collagen and partially resorbable hydroxyapatite/tricalcium phosphate (HA / {}-TCP) ceramic. The bovine fibrillar collagen component is biocompatible and has low immunogenicity, making it a suitable material for providing a scaffold around which new bone can grow. Both hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP) ceramic are radiopaque and highly biocompatible. HA is a polycrystalline substance with a stoichiometry similar to bone mineral and is minimally resorbed as bone grows into the scaffold. The porous B-TCP ceramic has a stoichiometry similar to amorphous biologic precursors to bone. In addition, it is biodegradable and its biodegradation products can be reconstituted by the body to form new bone mineral, allowing for bone deposition to occur. The porous HA / B-TCP ceramic has been shown to possess an osteoconductive property for filling bone defects and it can evoke a biologic response similar to that of bone.

# EQUIVALENCE TO MARKETED PRODUCT

R and D Medical, LLC submits the following information to demonstrate that, for the purposes of FDA's regulation of medical devices, Formagraft Collagen Bone Graft Matrix is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

The intended use, design and functional characteristics of Formagraft Collagen Bone Graft Matrix and the predicate devices are substantially the same. These devices include Orquest, Inc. Healos Bone Graft Material (K012751); NeuColl, Inc. Collagraft Strip Bone Graft Matrix (K000122); Berkeley Advanced Biomaterials Inc. Bi-Ostetic (K023703) and Orthovita Vitoss Scaffold Foam (K032288). These devices all are intended to fill voids or gaps in osseous defects, are not intended to be load-bearing and consist of a variety of calcium compounds and, in three cases, collagen.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three parallel lines that curve at the bottom. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 2005

R and D Medical, LLC C/o Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130

Re: K050789

Rose Device Name: Formagraft™ Collagen Bone Graft Matrix Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 25, 2005 Received: March 28, 2005

Dear Mr. Larson:

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 for ass barraior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the 1125 2011 11:15 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and cosmeter fore, 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 may or saily of 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.

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

Page 2-Mr. Floyd G. Larson

This letter will allow you to begin marketing your device as described in your Section 510(k) I his icter will and w you've organ finding of substantial equivalence of your device to a legally premaired 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 dosire of Compliance at [phone] . Also, please note the regulation entitled, Connect the Office or Comparket 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,

K. Miriam Provost, Ph.D.

Miriam Provost, Ph.D. Acting 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): _k s50788

Device Name: Formagraft™ Collagen Bone Graft Matrix

Indications for Use:

Formagraft" Collagen Bone Graft Matrix is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). 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 the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Formagraft is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Formagraft should not exceed 30 mL.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

Styphe Cluske

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

Page 1 of 1

iv

510(k) Number_________________________________________________________________________________________________________________________________________________________________