POLYGRAFT BONE GRAFT SUBSTITUTE

K030288 · Osteobiologics, Inc. · MQV · Jul 17, 2003 · Orthopedic

Device Facts

• Record ID: K030288
• Device Name: POLYGRAFT BONE GRAFT SUBSTITUTE
• Applicant: Osteobiologics, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ BGS is intended to 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 with bone during the healing process.

Device Story

PolyGraft™ BGS is a resorbable bone void filler composed of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers, and surfactant. Provided as porous granules or preformed cylindrical plugs; intended for surgical use by clinicians to fill non-structural osseous defects resulting from trauma or surgery. The material is packed into the defect site, where it resorbs over time and is replaced by natural bone during the healing process. Benefits include providing a scaffold for bone regeneration in the extremities, spine, and pelvis.

Clinical Evidence

No human clinical data. Evidence consists of biocompatibility assessment and an in vivo rabbit metaphyseal defect study. Rabbit study compared bone formation and biomechanical properties of PolyGraft™ BGS against predicate devices at six weeks, showing equivalent histological bone formation and biomechanical performance.

Technological Characteristics

Resorbable bone void filler; composition: poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers, and surfactant. Form factor: porous granules or preformed cylindrical plugs. Resorption mechanism: material resorbs and is replaced by bone. Non-electronic, non-software device.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities, spine, pelvis) caused by trauma or surgery, provided the defects are not 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

• Wright Plaster of Paris Pellets (K963562)
• ProOsteon™ 500R (K980817)

Submission Summary (Full Text)

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## JUL 1 7 2003

## 510(k) SUMMARY

| Submitter | Contact |
|--------------------------------------|--------------------------------------|
| Image: OBI OsteoBiologics, Inc. logo | Gabriele G. Niederauer, Ph.D. |
| OsteoBiologics, Inc. | Director of Research and Development |
| 12500 Network, Suite 112 | Phone: [phone] (ext. 228) |
| San Antonio, Texas 78249 | Fax: [phone] |
| USA | E-mail: [e-mail] |

| Date of Summary: | January 24, 2003 |
|------------------------|---------------------------------------------------------------------------------------------------------|
| Revised: | July 9, 2003 |
| Common Name: | Resorbable Bone Void Filler |
| Proprietary Name: | PolyGraft™ BGS; Bone Graft Substitute |
| Device Classification: | Resorbable calcium salt bone void filler (Product Code 87MQV) is a Class II device, per 21 CFR 888.3045 |
| 510(k) Number: | K030288 |

Description of Device: PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGraft™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.

Intended Use: The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ BGS is intended to 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 with bone during the healing process.

Substantial Equivalence: The PolyGraft™ BGS is substantially equivalent in design, function and intended use to the Wright Plaster of Paris Pellets cleared as K963562 on May 7, 1997 and ProOsteon™ 500R cleared as K980817 on Sept. 25, 1998.

Testing: Biocompatibility assessment performed by independent certified laboratories demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a simulated body fluid at 37 ℃ showed that the degradation rate is substantially equivalent to the predicate devices. OsteoBiologics performed a rabbit metaphyseal defect study to compare the bone formation of the PolyGraft™ BGS to the predicate devices. At six weeks, the PolyGraff™ BGS histologically showed bone formation similar to the predicate devices. Similarly, biomechanical properties of the bone defects treated with these graft materials were equivalent. The results from this side-by-side in vivo comparison demonstrated that PolyGraft™ BGS are substantially equivalent to the predicate devices, therefore supporting the suitability of the PolyGraft™ BGS for use in a clinical situation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/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 horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

JUL 17 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gabriele G. Niederauer, Ph.D. Director of Research and Development Osteobiologics 12500 Network, Suite 112 San Antonio, TX 78249-3308

Re: K030288

Trade Name: PolyGraft BGS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: June 25, 2003 Received: June 26, 2003

Dear Dr. Niederauer:

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 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 (OS) 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 - Gabriele G. Niederauer, Ph.D.

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.

L. Mark A. Wilkerson

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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## Indications for use (form)

(

:

| INDICATIONS FOR USE | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K030288 |
| Device Name: | Polygraft BGS |
| Indications For Use: | The Polygraft BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The Polygraft BGS is intended to 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 with bone during the healing process. |

(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

| 510(k) Number | K030288 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use |
|------------------------------------------|-------------------------|
|------------------------------------------|-------------------------|

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